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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	41415-047-75	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	41415-047-75	`9bebd1f3094a…`	`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
Ingredient	Strength
HYDROCORTISONE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WI4X0X7BPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
106258	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
29296b0f-0eed-4bb9-8727-c25c2bcf9fd6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
41415-047-75	2021-12-02	C162847	48780-1	9d75b9d1-0bc4-f424-e053-dadaa90a57ce	Publix Hydrocream
41415-047-75	2020-01-31	C162847	48780-1	9d75b9d1-0bc4-f424-e053-dadaa90a57ce	Publix Hydrocream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41415-047-75	PublixHydro	1 in 1 CARTON	CREAM	1		5
41415-047-75	PublixHydro	28.4 g in 1 TUBE	CREAM	28.4		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
sodium cetostearyl sulfate	INACTIVE INGREDIENT	7ZBS06BH4B	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41415-047	PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]	4	Current NDC, Legacy NDC, 2 package rows	20241211_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 152 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bactine Max Lidocaine Roll-on 2.5oz	LIDOCAINE	WellSpring Pharmaceutical Corporation	09b32a98-9131-451e-87a6-81a1e4ed7ec5	2023-04-25	Warnings	Exact identifier application number: M017
Icy Hot Pro Dry	CAMPHOR, MENTHOL	Chattem, Inc.	4de1bc29-d166-4599-9e75-5f841bf20967	2023-03-01	Warnings	Exact identifier application number: M017
Icy Hot Vanishing Scent	MENTHOL	Chattem, Inc.	e2092016-9741-433d-92e6-74bfddadb72c	2022-09-29	Warnings	Exact identifier application number: M017
New Terocin	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	Alexso, Inc	5dbd5fc0-a27e-4979-aca7-28f73096fd5f	2022-08-18	Warnings	Exact identifier application number: M017
FIRSTAR Sting Relief Pad	BENZOCAINE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	0e491a7a-4204-439f-862d-741cbc0be9fd	2021-07-06	Warnings	Exact identifier application number: M017
Arthritis Relief GoodSense	TROLAMINE SALICYLATE	Geiss, Destin & Dunn, Inc	a253730a-2187-07de-e053-2a95a90a9877	2020-04-02	Warnings	Exact identifier application number: M017
Aloe Cort	HYDROCORTISONE	Topiderm, Inc.	789a6669-3320-4558-8d6f-ab255db50d8d	2019-09-17	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	Borden Company (Private) Limited	567b6820-fb52-630e-e063-6294a90a8bf8	2015-07-01	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	54e45d89-e8c3-6fc3-e063-6394a90aac4e	2015-06-15	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106258	hydrocortisone 1 % Topical Cream	PSN	29296b0f-0eed-4bb9-8727-c25c2bcf9fd6	5
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	29296b0f-0eed-4bb9-8727-c25c2bcf9fd6	5
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	29296b0f-0eed-4bb9-8727-c25c2bcf9fd6	5
106258	hydrocortisone 1 % Topical Cream	SY	29296b0f-0eed-4bb9-8727-c25c2bcf9fd6	5
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	29296b0f-0eed-4bb9-8727-c25c2bcf9fd6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41415-047-75	41415004775	1 TUBE in 1 CARTON (41415-047-75) / 28.4 g in 1 TUBE	1 tube	2009-01-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Publix Hydrocream	Publix Super Markets Inc \| Sun Pharma Canada Inc.	2025-07-08	HUMAN OTC DRUG LABEL	5