FDA.reportPublic FDA data

NDC 51672-1301-02 - Ammonium Lactate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-1301
Requested NDC
51672-1301-02
Package NDCs from labels
51672-1301-4, 51672-1301-0, 51672-1301-2, 51672-1301-02
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2026-08-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ammonium Lactate Cream 12%*Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2026-08-17HUMAN PRESCRIPTION DRUG LABEL
Ammonium Lactate Cream 12%*REMEDYREPACK INC.2026-04-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1301-0Ammonium Lactate385 g in 1 BOTTLE, PLASTICCREAM3858
51672-1301-2Ammonium Lactate140 g in 1 TUBECREAM1408
51672-1301-2Ammonium Lactate1 in 1 CARTONCREAM18
51672-1301-4Ammonium Lactate2 in 1 CARTONCREAM28
51672-1301-4Ammonium Lactate140 g in 1 TUBECREAM1408

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1301AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]7Current NDC, Legacy NDC, 5 package rows20240922_9745b6ce-f532-4e80-b6e9-477ab9db4e30.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1301-0GM - Gram51672-1301b5fa1882-d4f1-4e01-a2f5-34f3bc293f4212012-07-24
51672-1301-2GM - Gram51672-1301de135ead-9564-4e4f-8a3f-b686bf6adea712024-10-04
51672-1301-4GM - Gram51672-1301a148ad99-5bd0-4e0f-a744-ca5b34f0de6d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ammonium LactateACTIVE INGREDIENT67M901L9NQAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
Lactic acidACTIVE MOIETY33X04XA5ATAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
cetyl alcoholINACTIVE INGREDIENT936JST6JCNAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
laureth-4INACTIVE INGREDIENT6HQ855798JAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
light mineral oilINACTIVE INGREDIENTN6K5787QVPAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
PEG-100 stearateINACTIVE INGREDIENTYD01N1999RAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9IAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 29 · 568 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Ammonium LactateAMMONIUM LACTATESun Pharmaceutical Industries, Inc.9745b6ce-f532-4e80-b6e9-477ab9db4e302026-08-17Warnings, Adverse reactionsExact identifier
application number: ANDA075883
ndc (package): 51672-1301-0
ndc (package): 51672-1301-4
ndc (package): 51672-1301-2
ndc (product): 51672-1301
ndc11 (package): 51672130102
rxcui: 543460
spl id: 593e7b4f-b89a-b746-e063-6394a90aa570
spl set id: 9745b6ce-f532-4e80-b6e9-477ab9db4e30
unii: 67M901L9NQ
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ammonium LactateAMMONIUM LACTATESun Pharmaceutical Industries, Inc.8bb09bb3-5bbc-489d-96c1-ae97cb58381e2026-07-30Warnings, Adverse reactionsExact identifier
unii: 67M901L9NQ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.