FDA.reportPublic FDA data

Publix

Product NDC
41415-047
11-digit product format
414150047
Labeler code
41415
Product ID
41415-047_397279ac-be74-ab1c-e063-6394a90ae7f1
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Publix Super Markets Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-08-23
Substance
HYDROCORTISONE
Active strength
1 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage41415-047-75e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage41415-047-759bebd1f3094a…5416666fcb17…

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
Publix
Brand name suffix
Hydro
Listing expiration
2026-12-31

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
29296b0f-0eed-4bb9-8727-c25c2bcf9fd6Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41415-047-752021-12-02C16284748780-19d75b9d1-0bc4-f424-e053-dadaa90a57cePublix Hydrocream
41415-047-752020-01-31C16284748780-19d75b9d1-0bc4-f424-e053-dadaa90a57cePublix Hydrocream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41415-047-75PublixHydro1 in 1 CARTONCREAM15
41415-047-75PublixHydro28.4 g in 1 TUBECREAM28.45

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZEPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
sodium cetostearyl sulfateINACTIVE INGREDIENT7ZBS06BH4BPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
waterINACTIVE INGREDIENT059QF0KO0RPUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41415-047PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]4Current NDC, Legacy NDC, 2 package rows20241211_29296b0f-0eed-4bb9-8727-c25c2bcf9fd6.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 64 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154fd46e-f00d-1772-e063-6394a90aba7d2025-11-12WarningsExact identifier
application number: M017
Best Choice Itch StoppingDIPHENHYDRAMINE HCLValu Merchandisers884cfd64-2cd1-8c12-e053-2995a90a89252025-11-12WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HCLCVS8839149d-e6d5-57cc-e053-2995a90a98322025-11-12WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HCLChain Drug Marketing Association884c9b47-d511-1d17-e053-2995a90a42eb2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 1BENZOCAINESambria Pharmaceuticals, LLC2f8fdcac-b87a-4191-9504-480a473f95cc2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 2LIDOCAINESambria Pharmaceuticals, LLC180b2899-7699-40e2-974a-081a6ce2bca22025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 3TETRACAINESambria Pharmaceuticals, LLC9c24dcff-3988-40eb-821a-fd4b0c85f5282025-11-12WarningsExact identifier
application number: M017
Tattoo Numbing Cream CoLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC2a64b3ef-ed2d-49db-996d-f63ffecb5a1e2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo NumbingLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCefd3289f-dfb2-487c-a76f-00fe8af414e32025-11-12WarningsExact identifier
application number: M017
Now Numb Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCfed833f5-4f76-46e8-8ae1-655a9e576f702025-11-12WarningsExact identifier
application number: M017
Painless Tattoo Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC852504ec-d4fa-4cae-ba89-7ffb57df8efe2025-11-12WarningsExact identifier
application number: M017
Arte Maximum strength Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCe612a256-3f44-46db-bb6a-e550c2216fdc2025-11-12WarningsExact identifier
application number: M017
Hello SugarLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC5f30254d-a28f-443d-8729-5c5dde4a02172025-11-12WarningsExact identifier
application number: M017
YULAM DIE DA WAN HUA PAIN RELIEVINGMENTHOL AND CAMPHORMADISON ONE ACME INC1ba3c31b-2737-4b55-a0ea-90013a1d8cf42025-11-12Warnings, Adverse reactionsExact identifier
application number: M017
TattooNumbLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCd9c4d664-54de-40c2-8836-72b60e6d9ac02025-11-12WarningsExact identifier
application number: M017
BeardedMoneyLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC35ff688b-75c5-4780-b294-192af780d7052025-11-12WarningsExact identifier
application number: M017
NeuroMed 7 Topical Pain ReliefLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCf199f56b-d971-4cf8-834d-babb5c2ff81a2025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Anesthetic 7LIDOCAINE HYDROCHLORIDESambria Pharmaceuticals8a2b6b76-6bcc-4f52-b037-e6cbc74f83772025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Anesthetic 7LIDOCAINE HYDROCHLORIDESambria Pharmaceuticals67b25c37-db32-4980-88b0-b077123459392025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Analgesic LATETRACAINE HCLSambria Pharmaceuticals, Inc.3c1e3a1d-f42b-499d-a445-1d1d3dd26c192025-11-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN29296b0f-0eed-4bb9-8727-c25c2bcf9fd65
106258hydrocortisone 10 MG/ML Topical CreamSCD29296b0f-0eed-4bb9-8727-c25c2bcf9fd65
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY29296b0f-0eed-4bb9-8727-c25c2bcf9fd65
106258hydrocortisone 1 % Topical CreamSY29296b0f-0eed-4bb9-8727-c25c2bcf9fd65
106258hydrocortisone 1 GM per 100 GM Topical CreamSY29296b0f-0eed-4bb9-8727-c25c2bcf9fd65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41415-047-75414150047751 TUBE in 1 CARTON (41415-047-75) / 28.4 g in 1 TUBE1 tube2009-01-230000-00-00NoNoCurrent