FDA.reportPublic FDA data

equate hydrocortisone

Product NDC
49035-707
Requested package NDC
49035-707-01
11-digit product format
490350707
Labeler code
49035
Product ID
49035-707_33860e7f-9196-4958-b0cc-98504d99261e
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Wal-Mart Stores Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-13
Substance
HYDROCORTISONE
Active strength
1 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
equate hydrocortisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1 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
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
70f4636d-4137-498b-ab81-0330de883e53Available 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
49035-707-01equate hydrocortisone1 in 1 CARTONCREAM18
49035-707-01equate hydrocortisone28 g in 1 TUBECREAM288
49035-707-16equate hydrocortisone56 g in 1 TUBECREAM568
49035-707-16equate hydrocortisone1 in 1 CARTONCREAM18
49035-707-64equate hydrocortisone28 g in 1 TUBECREAM288
49035-707-64equate hydrocortisone1 in 1 CARTONCREAM18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-707-64GM - Gram49035-70731e91f4c-e180-487b-8b95-e306b106760412019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJEQUATE HYDROCORTISONE (HYDROCORTISONE) CREAM [WAL-MART STORES INC]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJEQUATE HYDROCORTISONE (HYDROCORTISONE) CREAM [WAL-MART STORES INC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XEQUATE HYDROCORTISONE (HYDROCORTISONE) CREAM [WAL-MART STORES INC]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SEQUATE HYDROCORTISONE (HYDROCORTISONE) CREAM [WAL-MART STORES INC]2
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XEQUATE HYDROCORTISONE (HYDROCORTISONE) CREAM [WAL-MART STORES INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUATE HYDROCORTISONE (HYDROCORTISONE) CREAM [WAL-MART STORES INC]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSEQUATE HYDROCORTISONE (HYDROCORTISONE) CREAM [WAL-MART STORES INC]2
ISOSTEARYL NEOPENTANOATEINACTIVE INGREDIENT411THY156QEQUATE HYDROCORTISONE (HYDROCORTISONE) CREAM [WAL-MART STORES INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEQUATE HYDROCORTISONE (HYDROCORTISONE) CREAM [WAL-MART STORES INC]2
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYEQUATE HYDROCORTISONE (HYDROCORTISONE) CREAM [WAL-MART STORES INC]2
WATERINACTIVE INGREDIENT059QF0KO0REQUATE HYDROCORTISONE (HYDROCORTISONE) CREAM [WAL-MART STORES INC]2

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 98 of 147 · 2,937 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CBD Clinic Relax MassageCAMPHORABACUS HEALTH PRODUCTS, INC.f0eae24e-09cf-0d2d-e053-2a95a90acedc2025-01-28WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 5MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0ebbc0f-9888-b812-e053-2a95a90a5d3d2025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Arthritis Aches and Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec7255-bb36-41cd-e053-2a95a90aeac42025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Back and Neck Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec8fc9-c401-5f23-e053-2995a90acb1c2025-01-28WarningsExact identifier
application number: M017
Muscle TherapyMETHYL SALICYLATE, CAMPHOREverlaan Organics Inc0890a683-9a66-fdbd-e063-6294a90ae5262025-01-27WarningsExact identifier
application number: M017
Joint TherapyCAMPHOREverlaan Organics Inc08904b77-d6db-8b82-e063-6394a90ace4f2025-01-27WarningsExact identifier
application number: M017
Warrior Arthritis ReliefTROLAMIN SALICYLATE 10%Derma Care Research Labs, LLC013f48b9-913f-b283-e063-6394a90abd732025-01-27WarningsExact identifier
application number: M017
DCH Cool and HeatMENTHOL 16%Derma Care Research Labs, LLCff323282-612c-eaf8-e053-6394a90ab7792025-01-27WarningsExact identifier
application number: M017
GerigentleHYDROCORTISONEGERI-GENTLE CORPORATION0adfa2f0-9758-5c54-e063-6294a90a461f2025-01-25WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative Inc.42f1abeb-f6d7-01c3-e054-00144ff88e882025-01-23WarningsExact identifier
application number: M017
FORTHiQ Pain Relief Lidocaine PatchPAIN RELIEF LIDOCAINE PATCHHenan Enokon Medical Instrument Co., Ltd.2c593420-5788-3422-e063-6394a90a18902025-01-22WarningsExact identifier
application number: M017
RETALIEF LIDOCAINE 5LIDOCAINEReliable 1 Laboratories LLC2c262f3c-8cb2-4384-e063-6294a90a436d2025-01-20WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1c3e5068-dd61-ebdb-e063-6294a90a97cc2025-01-20WarningsExact identifier
application number: M017
PROHEAL BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab12025-01-19WarningsExact identifier
application number: M017
HERSTAT PLUS Cold Sore TreatmentCAMPHOR, MENTHOLHerstat (USA) Inc.e20ea714-663d-c4ac-e053-2a95a90a5ecc2025-01-18WarningsExact identifier
application number: M017
Pain Relief MedicatedCAMPHOR MENTHOL METHYL SALICYTATERITE AID CORPORATION60895211-69f3-478b-a33f-1c2071f629502025-01-16WarningsExact identifier
application number: M017
Elgin Pain ReliefMENTHOLEco-Logics, Inc.70eda21e-e566-42f4-9a49-b0d3ad0006522025-01-16WarningsExact identifier
application number: M017
Curist Lidocaine Patch Maximum StrengthLIDOCAINELittle Pharma, Inc.e574c188-cc65-287d-e053-2995a90a59722025-01-16WarningsExact identifier
application number: M017
Equate Hydrocortisone TopicalHYDROCORTISONEWalMart1f64555d-f77e-4a83-b222-fdb3ed7d88532025-01-16WarningsExact identifier
application number: M017
Equate HydrocortisoneHYDROCORTISONEWalMartf5c32b4a-1159-4b7a-b8ac-256d53020dc22025-01-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN70f4636d-4137-498b-ab81-0330de883e538
106258hydrocortisone 10 MG/ML Topical CreamSCD70f4636d-4137-498b-ab81-0330de883e538
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY70f4636d-4137-498b-ab81-0330de883e538
106258hydrocortisone 1 % Topical CreamSY70f4636d-4137-498b-ab81-0330de883e538
106258hydrocortisone 1 GM per 100 GM Topical CreamSY70f4636d-4137-498b-ab81-0330de883e538

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49035-707-01490350707011 TUBE in 1 CARTON (49035-707-01) / 28 g in 1 TUBE1 tube2025-11-26NoNoCurrent