Prescription medicine

Aspirin and caffeine and orphenadrine Brand names: Norgesic, Orphengesic; first approved as Norgesic Forte

Aspirin and caffeine and orphenadrine (Norgesic) is a prescription medicine with an FDA approval on record since 1964. FDA's NDC Directory lists it from 3 generic labelers.

Generic listed

Check it at the source: the aspirin and caffeine and orphenadrine FDA label on DailyMed (effective January 8, 2026, Galt Pharmaceuticals, LLC); the NDA 13416 record on Drugs@FDA; every aspirin and caffeine and orphenadrine label on DailyMed.

Highlights of the record

FDA label of January 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Norgesic TM (orphenadrine citrate, aspirin and caffeine 25 mg/ 385 mg/ 30 mg) Tablets are indicated in: Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders.

Forms and strengths

25 mg / 385 mg / 30 mg
50 mg / 770 mg / 60 mg

Tablet; multilayer tablet.

On the market

Earliest approval on file: March 4, 1964 Norgesic Forte, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 4 first November 27, 1996; 1 with a marketed status in Drugs@FDA
Labelers listed (NDC): 3 of which 3 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 128 through July 30, 2026

What is aspirin and caffeine and orphenadrine used for?

From the label: indications and usage
Norgesic TM (orphenadrine citrate, aspirin and caffeine 25 mg/ 385 mg/ 30 mg) Tablets are indicated in: Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Norgesic TM Tablets do not directly relax tense muscles in man.

Conditions named in the indications of aspirin and caffeine and orphenadrine's FDA labels, with every medicine labeled for each:

FDA pharmacologic class: Central Nervous System Stimulant, Methylxanthine, Muscle Relaxant, Nonsteroidal Anti-inflammatory Drug and Platelet Aggregation Inhibitor.

Source: FDA drug label (Norgesic), Galt Pharmaceuticals, LLC, effective January 8, 2026 (SPL set be2761bc-e537-4039-846a-2ffa3d8b2afc), via openFDA; the full label on DailyMed

Is there a generic for aspirin and caffeine and orphenadrine (Norgesic)?

The FDA approved the first generic aspirin and caffeine and orphenadrine on November 27, 1996. 4 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists aspirin and caffeine and orphenadrine from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1964 earliest approval on file
1996 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for aspirin and caffeine and orphenadrine?

The FDA Adverse Event Reporting System holds 128 reports that list aspirin and caffeine and orphenadrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8 are coded as a death and 39 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Nausea (named in the label)17
Drug Hypersensitivity11
Headache (named in the label)11
Fatigue10
Vision Blurred10
Dizziness (named in the label)9
Hypoaesthesia9
Diarrhoea8

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as aspirin and caffeine and orphenadrine?

18 other medicines are given the same way (oral) and in the same FDA class as aspirin and caffeine and orphenadrine or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Ibuprofen	Pain	273 labelers	$0.0573 per tablet 800 mg tablet	No current entry
Naproxen	Pain	146 labelers	$0.0565 per tablet 500 mg tablet	No current entry
Cyclobenzaprine	Muscle spasms and spasticity	60 labelers	$0.0171 per tablet 10 mg tablet	No current entry
Celecoxib	Pain	65 labelers	$0.0762 per capsule 200 mg capsule	No current entry
Diclofenac	Pain	67 labelers	$0.0619 per tablet 75 mg tablet	A presentation being discontinued
Methocarbamol	Muscle spasms and spasticity	54 labelers	$0.0395 per tablet 500 mg tablet	No current entry
Meloxicam	Pain	43 labelers	$0.0166 per tablet 7.5 mg tablet	No current entry
Etodolac	Pain	30 labelers	$0.262 per tablet 400 mg tablet	No current entry

Every medicine labeled for the same conditions as aspirin and caffeine and orphenadrine

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to aspirin and caffeine and orphenadrine: 18 medicines for the same use
Other stimulants: the pharmacologic class, with prices and generics
Aspirin and caffeine and orphenadrine side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other