FDA.reportPublic FDA data

CAREALL Hydrocortisone

Product NDC
51824-050
11-digit product format
518240050
Labeler code
51824
Product ID
51824-050_d36efb97-adb6-41e5-a077-1ea4d711fb05
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
New World Imports, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-11
Marketing end
2027-01-01
Substance
HYDROCORTISONE ACETATE
Active strength
1 g/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
CAREALL Hydrocortisone
Brand name suffix
Maximum Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE1 g/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea656cf8-cad5-4fa5-82e7-daec77a0bb04Available 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
51824-050-01CAREALL Hydrocortisone Maximum Strength28 g in 1 TUBECREAM287
51824-050-09CAREALL Hydrocortisone Maximum Strength.9 g in 1 PACKETCREAM.97
51824-050-14CAREALL Hydrocortisone Maximum Strength144 in 1 CONTAINERCREAM1447

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-050-01GM - Gram51824-050fe6ddcad-2e55-4288-b651-2bcb5a77576412020-03-10
51824-050-09EA - Each51824-05022b2e89d-523f-40d4-bff6-7430d185fb6512024-05-16
51824-050-14EA - Each51824-050854864d8-662f-4d23-a390-5b96f1a28c8812024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-050CAREALL HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [NEW WORLD IMPORTS, INC]7Current NDC, Legacy NDC, 3 package rows20241009_ea656cf8-cad5-4fa5-82e7-daec77a0bb04.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 36 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAPSAICIN HEAT PatchCAPSAICIN HEAT PATCHHenan Enokon Medical Instrument Co., Ltd.49ac2045-2c07-af9a-e063-6294a90a052a2026-01-31WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED PatchCOLD AND HOT MEDICATED PATCHHenan Enokon Medical Instrument Co., Ltd.49ac6a7b-25d3-6dc4-e063-6394a90a99b62026-01-31WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED PatchCOLD AND HOT MEDICATED PATCHHenan Enokon Medical Instrument Co., Ltd.49aca763-be2a-cf38-e063-6294a90a092e2026-01-31WarningsExact identifier
application number: M017
PAIN RELIEF HOT PatchPAIN RELIEF HOT PATCHHenan Enokon Medical Instrument Co., Ltd.49ad128a-0f4c-085a-e063-6294a90ac9bb2026-01-31WarningsExact identifier
application number: M017
Walgreens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company3557d2e9-714a-4066-aa73-ea9e3363e5742026-01-30WarningsExact identifier
application number: M017
Alveora HEMORRHOID MASTERLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTERJiangxi Yudexi Pharmaceutical Co., LTD4996f96a-898e-de01-e063-6394a90a39072026-01-30WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Rite Aid Corporationb67af0c7-1ae8-4494-bb0e-d7f66ebca3522026-01-30Warnings, Adverse reactionsExact identifier
application number: M017
Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITISCAPSAICINOL PHARMA TECH,LLC48fdf9dc-05df-866d-e063-6294a90ae03a2026-01-30WarningsExact identifier
application number: M017
ROCKTAPE GO Kinesiology Tape and AnalgesicMENTHOL, METHYL SALICYLATEImplus Footcare, LLCb779c7d8-dbe6-472f-9282-6cced25cfd2e2026-01-29WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATEImplus Footcare, LLCde5f7add-1f2b-438a-ac17-753ebb53e6972026-01-29WarningsExact identifier
application number: M017
RockSauce Warming Massage Roll-OnMENTHOL, METHYL SALICYLATEImplus Footcare, LLC5a2d9c3a-67fc-4c1a-b1e8-62a93880397a2026-01-29WarningsExact identifier
application number: M017
Analgesic Dr. ColladoMENTHOL, METHYL SALICYLATELaboratorios Dr. Collado, S.Ac0dad2db-7c96-49b8-a451-bf8cfa7f798b2026-01-29WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATEImplus Footcare, LLC3121c7f7-d7e5-4ca9-9057-03edf9c94c562026-01-29WarningsExact identifier
application number: M017
Analgesic Gel Dr. Collado Menthol 4 Methyl SalicylateMENTHOL, METHYL SALICYLATELaboratorios Dr. Collado, S.A.87c22e6f-3ab0-47c3-94ea-48b3d1a95d9d2026-01-29WarningsExact identifier
application number: M017
ProCure Hydrocortisone Cream PlusHYDROCORTISONERooftop Consumer Health, Inc.fe334cae-e019-4397-8498-df3c923ae8b52026-01-29WarningsExact identifier
application number: M017
Red Oil Pain ReliefCAMPHOR (SYNTHETIC), MENTHOL, PHENOLThe Red Oil Company Inc1e36579a-72da-46ba-ac72-5960a11c08802026-01-29WarningsExact identifier
application number: M017
Extra Strength BalmCAPSICUM, MENTHOLNATURES FORMULAE HEALTH PRODUCTS LTD.498a5e2a-4de0-561c-e063-6394a90ac05c2026-01-29WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET POTENT PAIN RELIEF45c76956-db3f-3e84-e063-6394a90adce12026-01-29WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEWALMART STORES INCb82cfe42-f521-4784-8c60-98481524c5ec2026-01-29WarningsExact identifier
application number: M017
Equate Pain Relief Patch Camphor/Menthol/SalicylateCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Incb869848c-21e2-5ca2-e053-2995a90a86f22026-01-29WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-050-015182400500128 g in 1 TUBE (51824-050-01) 28 g2016-04-272027-01-01NoNoCurrent
51824-050-0951824005009.9 g in 1 PACKET (51824-050-09) 2016-04-270000-00-00NoNoCurrent
51824-050-1451824005014144 PACKET in 1 CONTAINER (51824-050-14) / .9 g in 1 PACKET (51824-050-09) 144 packet2022-05-012027-01-01NoNoCurrent