FDA.reportPublic FDA data

Medi-First 1% Hydrocortisone

Product NDC
47682-923
11-digit product format
476820923
Labeler code
47682
Product ID
47682-923_0f240364-56ee-c7e8-e063-6294a90a6d44
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Unifirst First Aid Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-01
Marketing end
2028-04-30
Substance
HYDROCORTISONE ACETATE
Active strength
10 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
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
Medi-First 1% Hydrocortisone

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3X7931PO74Internal 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
bd216f5d-f304-7d8d-e053-2a95a90aa9ceAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
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874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
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25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-923-73Medi-First 1% Hydrocortisone25 in 1 BOXCREAM254
47682-923-73Medi-First 1% Hydrocortisone0.9 g in 1 PACKETCREAM0.94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-923MEDI-FIRST HYDROCORTISONE 1% (HYDROCORTISONE ACETATE) CREAM MEDI-FIRST 1% HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [UNIFIRST FIRST AID CORPORATION]4Current NDC, Legacy NDC, 2 package rows20240118_bd216f5d-f304-7d8d-e053-2a95a90aa9ce.zip

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 57 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LenzaPro FlexLIDOCAINE/MENTHOLSOLA Pharmaceuticalsba498f1d-460b-f4e6-e053-2995a90a57552025-12-08WarningsExact identifier
application number: M017
LidaFlexLIDOCAINESOLA Pharmaceuticalsb9e49529-13b4-1b0b-e053-2995a90adc7a2025-12-08WarningsExact identifier
application number: M017
Rugby Menthol Hot Cold PatchMENTHOLRUGBY LABORATORIESc68d29c2-9b56-4994-e053-2a95a90ae60e2025-12-08WarningsExact identifier
application number: M017
Neuracin Topical GelNEURACIN TOPICAL ANALGESIC GELSOLA Pharmaceuticalsc3166926-30c2-2128-e053-2a95a90a0bf22025-12-08WarningsExact identifier
application number: M017
TriceptinLIDOCAINE / MENTHOL / METHYL SALICYLATESOLA Pharmaceuticalsef1b98ab-d2db-038c-e053-2995a90a94b42025-12-08WarningsExact identifier
application number: M017
SynoFlex PatchSYNOFLEX PATCHSola Pharmaceuticalsde2042c4-6c5e-7365-e053-2a95a90ada2a2025-12-08WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1NICOTINE TRANSDERMAL PATCHESPCHEERY LLC457c860b-091d-8350-e063-6294a90a2f982025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMPMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC457c9bd6-2e72-03e5-e063-6394a90a558c2025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMP ROLL-ONCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC3e552afc-9305-8825-e063-6294a90a1afe2025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMPCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC457d89aa-4a84-94a6-e063-6294a90a20c02025-12-08WarningsExact identifier
application number: M017
Gold Bond Medicated Anti-ItchPRAMOXINE HYDROCHLORIDE, MENTHOLGold Bond Co LLC4a2bd277-47dd-4ae6-9b4b-e0ae9aad226b2025-12-05WarningsExact identifier
application number: M017
Orajel for Cold Sores Double Medicated, CreamBENZOCAINE AND WHITE PETROLATUMChurch & Dwight Co., Inc.b8699a40-8464-ca02-e053-2995a90a42602025-12-05WarningsExact identifier
application number: M017
Thompson Hydrocortisone 1%HYDROCORTISONEThompsonf8740314-7e1f-815e-e053-6294a90a6eae2025-12-05WarningsExact identifier
application number: M017
JUST CBD SOOTHING UNSCENTEDLIDOCAINE HCLJust Brands LLC453f44e2-9e5b-8695-e063-6394a90a43892025-12-05WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC453fa1a7-368c-ae50-e063-6294a90a55072025-12-05WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC4540221f-cf9f-9b6a-e063-6294a90adec32025-12-05WarningsExact identifier
application number: M017
Gold Bond Extra StrengthMENTHOLGold Bond Co LLC3e84375f-95d3-420c-b222-02a7574125922025-12-04WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLCb3ec09b9-7511-0895-e053-2a95a90a78402025-12-04WarningsExact identifier
application number: M017
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLCd240e9b8-3506-42ab-8a50-05e8d3fac4ff2025-12-04WarningsExact identifier
application number: M017
BLT Skin CreamBENZOCAINE, LIDOCAINE, TETRACAINEM2B Pharma LLC9dc5db9d-9e0a-cd28-e053-2995a90a6bf72025-12-04WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNbd216f5d-f304-7d8d-e053-2a95a90aa9ce4
106258hydrocortisone 10 MG/ML Topical CreamSCDbd216f5d-f304-7d8d-e053-2a95a90aa9ce4
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYbd216f5d-f304-7d8d-e053-2a95a90aa9ce4
106258hydrocortisone 1 % Topical CreamSYbd216f5d-f304-7d8d-e053-2a95a90aa9ce4
106258hydrocortisone 1 GM per 100 GM Topical CreamSYbd216f5d-f304-7d8d-e053-2a95a90aa9ce4
1367204acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
198440acetaminophen 500 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN5d185f23-8af6-4e36-b514-5662986520a51
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN5d185f23-8af6-4e36-b514-5662986520a51
308761bismuth subsalicylate 262 MG Chewable TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
1043690hydrocortisone acetate 1 % Topical CreamPSN5d185f23-8af6-4e36-b514-5662986520a51
310965ibuprofen 200 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
311372loratadine 10 MG 24HR Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
995666meclizine HCl 25 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
1367204acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
198440acetaminophen 500 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD5d185f23-8af6-4e36-b514-5662986520a51
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD5d185f23-8af6-4e36-b514-5662986520a51
308761bismuth subsalicylate 262 MG Chewable TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
313884calcium carbonate 420 MG Chewable TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD5d185f23-8af6-4e36-b514-5662986520a51
310965ibuprofen 200 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
311372loratadine 10 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
995666meclizine hydrochloride 25 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
1367204APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51
198440APAP 500 MG Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY5d185f23-8af6-4e36-b514-5662986520a51
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY5d185f23-8af6-4e36-b514-5662986520a51
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY5d185f23-8af6-4e36-b514-5662986520a51
1043690hydrocortisone acetate 1 % Topical CreamSY5d185f23-8af6-4e36-b514-5662986520a51
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51
311372loratadine 10 MG 24 HR Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-923-734768209237325 PACKET in 1 BOX (47682-923-73) / .9 g in 1 PACKET25 packet2021-06-012028-04-30NoNoCurrent