FDA.reportPublic FDA data

NDC 51672-3007-01 - Hydrocortisone and Acetic Acid

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
51672-3007
Requested NDC
51672-3007-01
Package NDCs from labels
51672-3007-1, 51672-3007-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone 1% and Acetic Acid 2% Otic SolutionSun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-3007-1Hydrocortisone and Acetic Acid10 mL in 1 BOTTLESOLUTION106
51672-3007-1Hydrocortisone and Acetic Acid1 in 1 CARTONSOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-3007HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 2 package rows20250112_6383c722-84e2-4719-a13d-19c54e3eefff.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-3007-1ML - Milliliter51672-30077be2481b-4a85-4ea9-838e-507e807baaa612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Acetic AcidACTIVE INGREDIENTQ40Q9N063PHYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
Acetic AcidACTIVE MOIETYQ40Q9N063PHYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLHYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
benzethonium chlorideINACTIVE INGREDIENTPH41D05744HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycol diacetateINACTIVE INGREDIENT5Z492UNF9OHYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium acetateINACTIVE INGREDIENT4550K0SC9BHYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2

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 45 · 898 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
unii: WI4X0X7BPJ
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEKroger Co.fe604470-917f-4cbd-a1e6-ac1dc7c57ff62026-09-02WarningsExact identifier
unii: PH41D05744
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsExact identifier
unii: WI4X0X7BPJ
Antibacterial BarANTIBACTERIAL BARGuangzhou Zeshi Daily Chemical Co.,Ltd.5a6f7c00-1dde-26b6-e063-6294a90a19e72026-09-01WarningsExact identifier
unii: PH41D05744
Terramed Just Think Comfort Hydrocortisone 1% CreamHYDROCORTISONERida LLC0d2c0c2c-370f-4adb-b0ea-1e218c927f8b2026-09-01WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEAmerican Health Packaging506aab0d-9308-4d60-90b3-7d64952fff362026-08-31Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinHYDROCORTISONEAmerisourceBergenc5c5b5ca-b4d4-4fa8-b647-b3ccb29664952026-08-30WarningsExact identifier
unii: WI4X0X7BPJ
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-27WarningsExact identifier
unii: WI4X0X7BPJ
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEAmazon.com Services LLC5f87d7fb-f258-48b0-8b60-1055e22ebd712026-08-25WarningsExact identifier
unii: WI4X0X7BPJ
PROCTOZONE-HCHYDROCORTISONE 2.5%Preferred Pharmaceuticals, Inc.5f055f94-b213-431b-897e-1c439660f1582026-08-21Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
ANTI ITCHHYDROCORTISONEHyVee Inc1ab6bbb8-2b91-4c53-9168-b1e85ac296e92026-08-19WarningsExact identifier
unii: WI4X0X7BPJ
hydrocortisone 1HYDROCORTISONEKroger Companyf05edff2-2dc5-427c-b52c-518e0aaef4e02026-08-19WarningsExact identifier
unii: WI4X0X7BPJ
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
Hydrocortisone with AloeHYDROCORTISONE CREAM 1/2%Sun Pharmaceutical Industries, Inc.59337940-c9be-58af-e063-6394a90abe132026-08-16WarningsExact identifier
unii: WI4X0X7BPJ
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
unii: WI4X0X7BPJ
HydralynHYDRALYNOncora Pharma, LLC835f0335-0215-4955-9099-b601604916952026-08-12Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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