Prescription medicine
Ammonium lactate First approved as Lac-Hydrin
Ammonium lactate (Lac-Hydrin) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.0668 per gram (Ammonium lactate 12% cream) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the ammonium lactate FDA label on DailyMed (effective November 30, 2025, Padagis Israel Pharmaceuticals Ltd); the NDA 19155 record on Drugs@FDA; every ammonium lactate label on DailyMed.
Highlights of the record
FDA label of November 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAmmonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.
Forms and strengths
- 12 g/100g
- 120 mg/g
Cream; lotion.
On the market
- Earliest approval on file
- April 24, 1985 Lac-Hydrin, Sun Pharm Inds Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first May 1, 2002; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 7 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0668 per gram Ammonium lactate 12% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,119 through July 30, 2026
What is ammonium lactate used for?
From the label: indications and usageAmmonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.
FDA pharmacologic class: alpha-Hydroxy Acid.
Source: FDA drug label (Ammonium Lactate), Padagis Israel Pharmaceuticals Ltd, effective November 30, 2025 (SPL set 7096d38e-2bd1-4374-9bf6-7fd09ef7509c), via openFDA; the full label on DailyMed
Is there a generic for ammonium lactate (Lac-Hydrin)?
The FDA approved the first generic ammonium lactate on May 1, 2002. 8 generic applications are approved; 6 of them carry 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 ammonium lactate from 7 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.
- 1985 earliest approval on file
- 2002 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ammonium lactate (Lac-Hydrin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0668 per gram (Ammonium lactate 12% cream), down 4% from $0.0697 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ammonium lactate 12% cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ammonium lactate 12% cream | Generic | $0.0668 per gram | n/a | -4% |
| Ammonium lactate 12% lotion | Generic | $0.0728 per gram | n/a | +7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for ammonium lactate?
The FDA Adverse Event Reporting System holds 2,119 reports that list ammonium lactate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 175 are coded as a death and 578 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Ammonium lactate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other