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 4 of 44 · 877 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intensive Healing Itch ReliefITCH RELIEF CREAMNeilMed Pharmaceuticals Inc563ef1d5-2180-bc45-e063-6294a90a813d2026-07-10WarningsExact identifier
unii: WI4X0X7BPJ
Drs. Hydrocortisone Aloe VeraHYDROCORTISONEOL PHARMA TECH,LLC0df06415-5d32-7ef8-e063-6294a90a6e5a2026-07-09WarningsExact identifier
unii: WI4X0X7BPJ
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.560a4abf-31dd-333f-e063-6294a90a35052026-07-08WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONE LOTIONAllegis Holdings LLC1a27d8fa-4025-ed68-e063-6394a90a4f372026-07-08Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Ala-ScalpHYDROCORTISONEDerm Ventures LLC61498a40-3b3c-4066-89c8-d99686e2d6382026-07-08Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
CVS No Mess CortisoneHYDROCORTISONENatural Essentials, Inc.558c94ec-95f1-eb98-e063-6394a90a1e722026-07-01WarningsExact identifier
unii: WI4X0X7BPJ
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEHudson Health LLC42789576-0ab4-1afb-e063-6294a90a1d272026-06-30WarningsExact identifier
unii: PH41D05744
HydrocortisoneHYDROCORTISONEEncube Ethicals, Inc.11e120e2-a1ca-477c-b474-bcbb726567052026-06-26Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas, LLC5517ee5f-1c51-cfd6-e063-6294a90af56f2026-06-25WarningsExact identifier
unii: WI4X0X7BPJ
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas LLC55188ede-68cd-fcc6-e063-6394a90a5c582026-06-25WarningsExact identifier
unii: WI4X0X7BPJ
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: Q40Q9N063P
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%NuCare Pharmaceuticals, Inc.54f07a23-213f-ca46-e063-6394a90a00342026-06-24WarningsExact identifier
unii: WI4X0X7BPJ
Benzethonium chloride and Dyclonine hydrochlorideLIQUID BANDAGETarget Corporation326daa64-165a-cea6-e063-6294a90afbab2026-06-22WarningsExact identifier
unii: PH41D05744
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
HydroxymHYDROCORTISONEPureTek Corporationfebffc84-e65e-e811-e053-6294a90a0ad12026-06-15Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HEALMUSZ ECZEMAHYDROCORTISONE 1% ECZEMAJiangxi Yudexi Pharmaceutical Co., LTD511e54e0-2abe-fb76-e063-6294a90ada682026-06-14WarningsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone 1% Anti-ItchCreamHYDROCORTISONEAcme United Corporation5425fc2b-4f25-3e64-e063-6394a90aff492026-06-13WarningsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Aldermed Inc.4a7b532e-b292-b595-e063-6394a90acc9c2026-06-12WarningsExact identifier
unii: WI4X0X7BPJ
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: XF417D3PSL
Benzethonium chloride and Dyclonine hydrochlorideLIQUID BANDAGEChain Drug Marketing Association34062b23-52aa-99ae-e063-6294a90ae73f2026-06-09WarningsExact identifier
unii: PH41D05744

Reported adverse events (FAERS/openFDA)#

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