FDA.reportPublic FDA data

Medi-First Hydrocortisone 1%

Product NDC
47682-207
11-digit product format
476820207
Labeler code
47682
Product ID
47682-207_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 Hydrocortisone 1%

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
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-207-12Medi-First Hydrocortisone 1%0.9 g in 1 PACKETCREAM0.94
47682-207-12Medi-First Hydrocortisone 1%10 in 1 BOXCREAM104
47682-207-35Medi-First Hydrocortisone 1%144 in 1 BOXCREAM1444
47682-207-35Medi-First Hydrocortisone 1%0.9 g in 1 PACKETCREAM0.94
47682-207-73Medi-First Hydrocortisone 1%0.9 g in 1 PACKETCREAM0.94
47682-207-73Medi-First Hydrocortisone 1%25 in 1 BOXCREAM254
47682-207-99Medi-First Hydrocortisone 1%0.9 g in 1 PACKETCREAM0.94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-207MEDI-FIRST HYDROCORTISONE 1% (HYDROCORTISONE ACETATE) CREAM MEDI-FIRST 1% HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [UNIFIRST FIRST AID CORPORATION]4Current NDC, Legacy NDC, 7 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 137 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relieving CoolingMENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.3574d48a-b546-4ea7-b470-071bb328de642024-02-08WarningsExact identifier
application number: M017
Advil Targeted ReliefCAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATEHaleon US Holdings LLC16e6be21-7b43-443a-89ec-3bdf0ec0dfc12024-02-08WarningsExact identifier
application number: M017
POINT RELIEF COLD SPOT Pain RelievingMENTHOLFABRICATION ENTERPRISES96f1d592-6cec-412e-a5fd-cf3c4f68644f2024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.1c5eb3b3-79b3-472a-ae36-ec6a7dc729252024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.8eb3e7e2-26e5-430e-89aa-40a0367c637e2024-02-07WarningsExact identifier
application number: M017
Nova Natura Topical AnalgesicCAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATESEYITLER KIMYA SANAYI ANONIM SIRKETIabf00f73-f0b1-439e-85aa-bbce8a1ec9202024-02-06WarningsExact identifier
application number: M017
Leader Burn ReliefLIDOCAINECardinal Healthf4e8e3b7-fd84-bdbc-e053-2a95a90aeab22024-02-06WarningsExact identifier
application number: M017
Pain Relieving Petro CarboPHENOLJ.R. Watkins, LLC.050cf17d-3be7-45b9-8524-ad82af309a0e2024-02-06WarningsExact identifier
application number: M017
White CreamCAMPHOR (NATURAL) AND TURPENTINE OILJ.R. Watkins, LLC.e4de0734-59d5-478c-86ea-66fc2ba003e72024-02-05WarningsExact identifier
application number: M017
Pain Relieving Roll-OnMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.80118260-9c88-402d-9a90-ecfe62b4b54f2024-02-05WarningsExact identifier
application number: M017
Pain RelievingMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.df512ce6-ce1b-434d-9571-fb2e1d76e1d02024-02-05WarningsExact identifier
application number: M017
Pain RelievingMENTHOLSafetec of America, Inc.52ebf64d-095f-467e-bf51-dd8d33b58c7d2024-02-05WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDESafetec of America, Inc.4f4c801b-d894-4fa3-b024-6ca41a5f2a952024-02-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.79e3b0e7-4ba5-4b9d-a980-5b6f18dba8022024-02-04WarningsExact identifier
application number: M017
HAV EZ Penetrating Pain ReliefMENTHOLPALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC70006efc-9cc8-4490-b28c-fcb23b1737c42024-02-01WarningsExact identifier
application number: M017
Rugby Capsaicin External AnalgesicCAPSAICINProficient Rx LP7c733a30-5002-49e7-a6bd-7737a1d2461e2024-02-01WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEProficient Rx LPccb62898-b614-45b9-95ea-23e5e31893a82024-02-01WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONEProficient Rx LP0b26d92f-9d0e-46d4-a8bc-75d6da5f61992024-02-01WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEProficient Rx LPc57d5f8e-5934-4cbb-999a-cdd55e5b105f2024-02-01WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEProficient Rx LP47e9fe84-bd0c-40ea-85de-e950bcacc5572024-02-01WarningsExact 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-207-124768202071210 PACKET in 1 BOX (47682-207-12) / .9 g in 1 PACKET10 packet2021-06-012028-04-30NoNoCurrent
47682-207-3547682020735144 PACKET in 1 BOX (47682-207-35) / .9 g in 1 PACKET144 packet2021-06-012028-04-30NoNoCurrent
47682-207-734768202077325 PACKET in 1 BOX (47682-207-73) / .9 g in 1 PACKET25 packet2021-06-012028-04-30NoNoCurrent
47682-207-9947682020799.9 g in 1 PACKET (47682-207-99) 2021-06-012028-04-30NoNoCurrent