FDA.reportPublic FDA data

Hydrocortisone 1% Anti-ItchCream

Product NDC
0924-5634
11-digit product format
009245634
Labeler code
0924
Product ID
0924-5634_5425ff8d-cc9d-e5ef-e063-6294a90a585f
Type
HUMAN OTC DRUG
Nonproprietary name
HYDROCORTISONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Acme United Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-30
Substance
HYDROCORTISONE
Active strength
10 mg/g
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 1% Anti-ItchCream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE10 mg/g

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
106258Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5425fc2b-4f25-3e64-e063-6394a90aff49Available 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 79 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALCEMISTELIDOCAINE HCLPrice Team Ventures, LLC4383faaa-49cf-47b7-83a6-c2a94b6ff9b52025-09-05WarningsExact identifier
application number: M017
Lansinoh Pain RelievingLIDOCAINE HCLLansinoh Laboratories Incb7cf1fdb-946d-a4e8-e053-2995a90a26a82025-09-05WarningsExact identifier
application number: M017
Sumifun PLANTAR RELIEF ROLL -ON4% LIDOCAINE, 1% MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd3c9ee60b-548a-979f-e063-6394a90a70b02025-09-03WarningsExact identifier
application number: M017
Meijer Capsaicin Heat PatchCAPSAICINMeijer Distribution3c465557-0a4f-fb72-e063-6294a90a1ef22025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC Ventures Corp DBA Cryodermdd95c682-8ddf-43e7-a277-2fca6ec744cc2025-09-02WarningsExact identifier
application number: M017
Pain RelievingMENTHOL, CAMPHOR, CAPSAICINAHC VENTURES CORP DBA CRY27679d31-a5f3-417b-b0c5-5f6b001ecff92025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERM52fff03e-eba2-4604-a71c-2522468f627b2025-09-02WarningsExact identifier
application number: M017
Pain Relieving Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERMde210c3a-c24e-cefd-e053-2a95a90a93ff2025-09-02WarningsExact identifier
application number: M017
Pain Relieving Roll-OnMENTHOL, CAMPHOR, CAPSAICINAHC VENTURES CORP DBA CRY799751f3-726a-42de-934e-dbc3cd1cb8b82025-09-02WarningsExact identifier
application number: M017
Pain Relieving Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERMde0c9a73-dbc0-599e-e053-2a95a90a79862025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERM90334420-5f81-4284-9a57-42e134ce362f2025-09-02WarningsExact identifier
application number: M017
KNEE PAIN RELIRF PatchCAMPHOR, MENTHOLShenzhen Finona Information Technology Co., Ltd3db971ef-d7fa-0171-e063-6294a90aa58b2025-09-01WarningsExact identifier
application number: M017
Bikini Zone Medicated CremeLIDOCAINEKingsway Pharmaceuticals dba NFI, LLC300ac57e-844a-4840-b285-41ff5518e6b62025-08-29WarningsExact identifier
application number: M017
Bikini Zone Medicated GelLIDOCAINEKingsway Pharmaceuticals dba NFI, LLC30b85890-e72d-4af7-bda9-e7744abc92af2025-08-29WarningsExact identifier
application number: M017
Sumifun Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3d7dc8cc-0680-d94d-e063-6394a90ac8e82025-08-29WarningsExact identifier
application number: M017
TKTALKER NUMBINGNUMBINGShenzhen Shandian Jingling Technology Co., Ltd.3d7e6757-f183-2a68-e063-6294a90ae4ca2025-08-29WarningsExact identifier
application number: M017
PBZ OTCTRIPELENNAMINE HCL 1%Kingsway Pharmaceuticals dba NFI, LLC12f72d74-018f-4bc6-acd4-175ca3af4c6d2025-08-29WarningsExact identifier
application number: M017
else.LIDOCAINEElse Co.3d6c7b10-ed03-bbde-e063-6294a90ae92f2025-08-28WarningsExact identifier
application number: M017
Mountain Ice Pain ReliefMENTHOLMountainside Medical Equipment, Inc.c79fdd91-16f4-4ae0-bee4-d37c05ed20742025-08-28WarningsExact identifier
application number: M017
HealthWise 4% Lidocaine Cream 2.7 ozLIDOCAINE HYDROCHLORIDEVeridian Healthcaref39eb3d0-e153-4f50-85b1-ad5c677d176c2025-08-28WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0924-5634-0000924563400.9 g in 1 PACKET (0924-5634-00) 2026-06-30NoNoCurrent
0924-5634-020092456340212 PACKET in 1 CARTON (0924-5634-02) / .9 g in 1 PACKET (0924-5634-00) 12 packet2026-06-30NoNoCurrent
0924-5634-040092456340425 PACKET in 1 CARTON (0924-5634-04) / .9 g in 1 PACKET (0924-5634-00) 25 packet2026-06-30NoNoCurrent