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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9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
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e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
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332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
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 70 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RELISPRAY NATURAL PAIN RELIEFMENTHOLMidas-Care Pharmaceuticals, Pvt. Ltdadc8a43c-19a1-4eb3-9820-b63f7b5e91ea2025-10-30WarningsExact identifier
application number: M017
Aveeno Anti-Itch ConcentratedZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC07f4d4d0-9cee-46c3-bc71-2024abd31c9e2025-10-29WarningsExact identifier
application number: M017
zourunan Relieve itching cream ANTIFUNGALRELIEVE ITCHING CREAMGuchutang Biotechnology (Longyan) Co., Ltd41bb9ced-dde4-2998-e063-6394a90a81592025-10-29WarningsExact identifier
application number: M017
zourunan Intensive healing lotion. for ECZEMAINTENSIVE HEALING LOTIONGuchutang Biotechnology (Longyan) Co., Ltd41bad9f3-f1a7-e92c-e063-6394a90ad0ba2025-10-29WarningsExact identifier
application number: M017
Aromalief Pain Relief Cream Orange GingerMENTHOLMarketites LLC9e8d3611-ef1b-4ac6-e053-2995a90af28a2025-10-29WarningsExact identifier
application number: M017
Aromalief Calming Pain Relief Cream LavenderMENTHOLMarketites LLCb8197d52-ccfb-b008-e053-2995a90a0a532025-10-29WarningsExact identifier
application number: M017
Aromalief Cozy Vanilla Pain Relief CreamMENTHOLMarketites LLC3634e55e-8c62-a782-e063-6394a90a65082025-10-29WarningsExact identifier
application number: M017
BENOVA PAIN AND ITCH RELIEFMENTHOL, 0.11%BENOVA RX LLC42513ee2-8b40-a9f3-e063-6394a90a93862025-10-29WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINECVS Pharmacy7e9285fd-26d5-3eac-e053-2991aa0ae2db2025-10-29WarningsExact identifier
application number: M017
Coralite Ultra Strength Pain ReliefCAMPHOR MENTHOLUnited Exchange Corp.44ecf959-cc07-4adc-a500-075b2ee695482025-10-29WarningsExact identifier
application number: M017
GoodSense Pain ReliefLIDOCAINEGeiss, Destin & Dunn, Inc826f8da4-8468-ea0a-e053-2991aa0a66cb2025-10-28WarningsExact identifier
application number: M017
CALMADOLCAMPHOR, MENTHOL, METHYL SALICYLATEGRANDALL DISTRIBUTING, LLC31b7f84e-8b66-4d31-8e9c-279d0af2fe642025-10-28WarningsExact identifier
application number: M017
XRay DOLCAMPHOR, MENTHOL, AND METHYL SALICYLATEGenomma Lab USA, Inc.e07fef46-68d9-769c-e053-2a95a90aa0652025-10-28WarningsExact identifier
application number: M017
CVS Medicated HeatCAPSICUM EXTRACTCVS Pharmacy81cd1019-93a6-311b-e053-2991aa0a79972025-10-28WarningsExact identifier
application number: M017
Foster and ThriveLIDOCAINESTRATEGIC SOURCING SERVICES, LLCf950b072-d978-b629-e053-6394a90abfaf2025-10-28WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
application number: M017
PRMENTHOLAmphp, Inc6f5b9e08-c445-4fac-e053-2a91aa0aa7372025-10-27WarningsExact identifier
application number: M017
LidocaineBURN RELIEFFoodhold USAb25dc0df-02d0-41ac-b36c-2c04baa77ef22025-10-27WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREEFSA Store Inc.fb3548c8-f202-dc50-e053-6394a90a5b302025-10-27WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CONTINUOUS SPRAYPremier Brands of America, Inc.d344f68b-9b62-3029-e053-2995a90a16652025-10-27WarningsExact 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