FDA.reportPublic FDA data

Hydrocortisone

Product NDC
51672-5335
11-digit product format
516725335
Labeler code
51672
Product ID
51672-5335_5933787d-8cc1-5959-e063-6394a90a9f80
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone Cream 1/2%
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-31
Substance
HYDROCORTISONE
Active strength
.5 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocortisone
Brand name suffix
with Aloe
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198707Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
59337940-c9be-58af-e063-6394a90abe13Available on FDA.report

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 52 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Large Medicate Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergena7d5f89b-59b9-4603-99aa-273b85be813e2025-12-22WarningsExact identifier
application number: M017
Good Neighbor Capsaicin Heat Patch for BackCAPSAICINAmerisource Bergenf873a0b8-8123-1600-e053-6394a90a043e2025-12-22WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Cold Therapy Pain Relief PatchMENTHOLAmerisource Bergenf872f371-b92c-f5d5-e053-6294a90a7dcd2025-12-22WarningsExact identifier
application number: M017
Caring Mills HydrocortisoneHYDROCORTISONEVeridian Healthcareb0b1889b-3099-4943-a4cb-d9a898a068602025-12-22WarningsExact identifier
application number: M017
LIDOCAINE 5%LIDOCAINEMedhome Pharma Inc46968f5a-d214-9871-e063-6394a90ab45d2025-12-22WarningsExact identifier
application number: M017
Blue-Emu THRIVE CoolingTRIPELENNAMINE 0.5%Kingsway Pharmaceuticals dba NFI, LLC7ac6456a-42c5-4ac8-aae6-db4abfda9df02025-12-22WarningsExact identifier
application number: M017
MENTHOLMENTHOLSUNSET PAIN RELIEF45c5ca6f-d425-6cfb-e063-6394a90a1b662025-12-20WarningsExact identifier
application number: M017
HERSTAT GST Genital Sore TreatmentCAMPHOR, MENTHOLHerstat (USA) Inc.e8d27684-fb15-2e6a-e053-2a95a90a248f2025-12-19WarningsExact identifier
application number: M017
Kroger Anti ItchHYDROCORTISONEThe Kroger Co46547277-f11a-b9e7-e063-6294a90a2ccd2025-12-19WarningsExact identifier
application number: M017
Kroger Cool and Heat Roll-OnMENTHOLKroger46551d07-3006-c3ec-e063-6294a90aa3f22025-12-19WarningsExact identifier
application number: M017
Naughty Kitty KatNO GAG DEEP THROAT SPRAYINKED SUGAR, INC170eb644-c72c-5744-e063-6394a90a767d2025-12-19WarningsExact identifier
application number: M017
Tiger Balm Red Extra StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.ce703715-4c11-472c-9270-daac87b7be052025-12-19WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Foot Pain CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.da82cc0e-cc39-408e-87e1-c35bb6f9f51e2025-12-19WarningsExact identifier
application number: M017
Health Trak Plus Menthol-Infused Pain Relief SocksMENTHOLRailroad Sock LLC43413e55-1db2-fc1a-e063-6394a90a71672025-12-18WarningsExact identifier
application number: M017
BIO-ICEMENTHOL, CAMPHORElectrostim Medical Services Inc. d/b/a EMSI1bfd1468-9139-43b1-9709-d47b63d17cfb2025-12-18WarningsExact identifier
application number: M017
LidotrodeLIDOCAINEStrand Health Group1fd20b9a-b8bc-c94f-e063-6394a90a2b692025-12-18WarningsExact identifier
application number: M017
A Health Itch Relief GelITCH RELIEF GELBionpharma, Inc.ecf5decb-c98b-7739-e053-2995a90a55412025-12-18WarningsExact identifier
application number: M017
After Burn2.5% LIDOCAINE HCLTender Corporation d/b/a Adventure Ready Brands4640395f-a76c-d022-e063-6294a90adde62025-12-18WarningsExact identifier
application number: M017
SPARTAN WIPESENDURANCE WIPESTIV PRIME SRL26d02431-2c95-001c-e063-6394a90a29c72025-12-18WarningsExact identifier
application number: M017
Stopain Extra Strength ContinuousMENTHOLTroy Manufacturing, Inc.a0f76968-d22c-4b1c-a9e6-8d0179a2e98e2025-12-18WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-5335-2516725335021 TUBE in 1 CARTON (51672-5335-2) / 28.4 g in 1 TUBE1 tube2026-07-31NoNoCurrent