FDA.reportPublic FDA data

Publix

Product NDC
41415-048
11-digit product format
414150048
Labeler code
41415
Product ID
41415-048_39727e97-e373-0837-e063-6294a90a98c7
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
1989-10-03
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41415-048-75557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage41415-048-758af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage41415-048-75834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage41415-048-751332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage41415-048-75e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage41415-048-759bebd1f3094a…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 plus
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
a00d82c1-6b09-424a-be78-2603eee3fb9dAvailable 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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct 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#

Effective, Related label table
EffectiveRelated label
2024-09-27Publix hydrocreamplus
2024-01-30Publix hydrocreamplus
2021-12-16Publix hydrocreamplus
2020-01-31Publix hydrocreamplus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41415-048-75Publixhydro plus28.4 g in 1 TUBECREAM28.44
41415-048-75Publixhydro plus1 in 1 CARTONCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0PUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
chamomile flower oilINACTIVE INGREDIENT60F80Z61A9PUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
cholecalciferolINACTIVE INGREDIENT1C6V77QF41PUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
corn oilINACTIVE INGREDIENT8470G57WFMPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4PUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZEPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
sodium cetostearyl sulfateINACTIVE INGREDIENT7ZBS06BH4BPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
Vitamin A palmitateINACTIVE INGREDIENT1D1K0N0VVCPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1
waterINACTIVE INGREDIENT059QF0KO0RPUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41415-048PUBLIX HYDRO PLUS (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]3Current NDC, Legacy NDC, 2 package rows20240929_a00d82c1-6b09-424a-be78-2603eee3fb9d.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 5 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RELIBONEOintmentTOPICAL ANALGESICOINTMENTGuangdong Jiaoyu Biotechnology Co., Ltd58ddaaf6-18ec-8c5b-e063-6294a90a28282026-08-12WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58de3a29-2bec-6e44-e063-6394a90a9c1a2026-08-12WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsExact identifier
application number: M017
Muscle Rub CreamMUSCLE RUBALLIED TRADE LINK LLC11d33e60-8c64-4316-a29a-d17e3e6e4a282026-08-11WarningsExact identifier
application number: M017
Gee GasonMALE GENITAL DESENSITIZERMon Gars Boutique Inc58c75e5c-b801-017f-e063-6394a90a1c752026-08-11WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58c84330-15bf-c397-e063-6394a90aba052026-08-11WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy0e988da1-1904-431d-a152-bdb2aacc8e162026-08-11WarningsExact identifier
application number: M017
Medicated BODYMENTHOLCVS Pharmacy, Inc.a0f61498-69c8-4ce0-bbd7-3a807f192d362026-08-11WarningsExact identifier
application number: M017
Muscle MoveMENTHOLSaje Natural Wellness Inc.526d3305-4cf8-2fc5-e063-6394a90ad53b2026-08-10WarningsExact identifier
application number: M017
Relieve and Relax Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLMAC Innovations, LLCc0528c36-d322-8110-e053-2995a90add6c2026-08-08WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOLCVS Pharmacy4aa629f5-8b8f-cc67-e063-6394a90a019f2026-08-07WarningsExact identifier
application number: M017
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsExact identifier
application number: M017
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy46921bea-fcbe-94d6-e063-6394a90a726b2026-08-07WarningsExact identifier
application number: M017
CVS Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Pharmacy524605f9-8b04-b600-e063-6394a90a4a022026-08-07WarningsExact identifier
application number: M017
LidonexLIDOCAINE HCL, MENTHOLAldama Pharmaceuticals, Inc365cf19c-70e0-c4e9-e063-6294a90ac4282026-08-07WarningsExact identifier
application number: M017
Blaster Pain Relief StickMENTHOL, METHYL SALICYLATE, CAMPHORKalahari Rose, LLC587d660a-5f80-de5a-e063-6394a90aa2872026-08-07WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECardinal Health, 110 dba Leader3ed7b8a1-012f-459d-878c-813b93d4673c2026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLThe Kroger Co.6fb0acc8-8dab-452c-b09e-de97306e1c322026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNa00d82c1-6b09-424a-be78-2603eee3fb9d4
106258hydrocortisone 10 MG/ML Topical CreamSCDa00d82c1-6b09-424a-be78-2603eee3fb9d4
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYa00d82c1-6b09-424a-be78-2603eee3fb9d4
106258hydrocortisone 1 % Topical CreamSYa00d82c1-6b09-424a-be78-2603eee3fb9d4
106258hydrocortisone 1 GM per 100 GM Topical CreamSYa00d82c1-6b09-424a-be78-2603eee3fb9d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41415-048-75414150048751 TUBE in 1 CARTON (41415-048-75) / 28.4 g in 1 TUBE1 tube1989-10-030000-00-00NoNoCurrent