Active ingredient
Lactate
19 finished FDA listings contain Lactate as their only active ingredient; 188 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- AMMONIUM LACTATE, LACTIC ACID, LACTIC ACID, L-, LACTIC ACID, UNSPECIFIED FORM, SODIUM LACTATE, SODIUM LACTATE, L-, ZINC LACTATE
- Dosage forms
- Cream, Liquid, Lotion, Pellet
- Routes
- Oral, Topical
- Manufacturers / labelers
- 9
- Strengths listed
- .02 g/100g · 1.6 g/100ml · 12 g/100g · 120 mg/g · 200 [kp_c]/200[kp_c] · 3 [hp_c]/3[hp_c] · 30 [hp_c]/30[hp_c] · 6 [hp_c]/6[hp_c] · 9 [hp_c]/9[hp_c]
- Brand names in FDA listings
- Key Dermolac, Sarcolacticum Acidum
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 114202
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 075774 | PADAGIS ISRAEL | 2002-05-01 | 4 |
| ANDA 075883 | SUN PHARMA CANADA | 2003-04-10 | 2 |
| ANDA 076216 | SUN PHARMA CANADA | 2004-05-28 | 2 |
| ANDA 075570 | PADAGIS ISRAEL | 2004-06-23 | 4 |
Official labeling on DailyMed
- AMMONIUM LACTATE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 9 · 2026-08-19
- AMMONIUM LACTATE LOTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 7 · 2026-08-03
- AMMONIUM LACTATE LOTION [PADAGIS ISRAEL PHARMACEUTICALS LTD] · version 11 · 2026-07-22
- ISHANCARE VAGINAL ANTIBACTERIAL GEL CREAM [SHENZHEN ISHAN TECHNOLOGY CO., LTD] · version 2 · 2026-05-12
- SARCOLACTICUM ACIDUM (LACTIC ACID, L-) PELLET [BOIRON] · version 4 · 2026-04-28
- AMMONIUM LACTATE CREAM [REMEDYREPACK INC.] · version 5 · 2026-04-15
- AMMONIUM LACTATE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] · version 13 · 2026-03-27
- KEY DERMOLAC (JABON ANTISEPTICO A BASE DE ACIDO LACTICO) LIQUID [KEY QUÍMICA S.A. DE C.V.] · version 2 · 2025-01-09
- AMMONIUM LACTATE CREAM [BRYANT RANCH PREPACK] · version 104 · 2024-04-15
- AMMONIUM LACTATE LOTION [BRYANT RANCH PREPACK] · version 100 · 2024-02-09
- SARCOLACTICUM ACIDUM (LACTIC ACID, L-) PELLET [BOIRON] · version 3 · 2024-01-26
- SARCOLACTICUM ACIDUM (LACTIC ACID, L-) PELLET [BOIRON] · version 3 · 2024-01-26
Showing the 12 most recent of 19 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.