Hydrocortisone Acetate

Product NDC: 51672-2069
11-digit product format: 516722069
Labeler code: 51672
Product ID: 51672-2069_44fe37d6-007d-8b3b-e063-6394a90ac802
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone Acetate
Dosage form: CREAM
Route: TOPICAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2001-06-01
Substance: HYDROCORTISONE ACETATE
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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51672-2069-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51672-2069-9	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51672-2069-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51672-2069-9	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51672-2069-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51672-2069-9	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51672-2069-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51672-2069-9	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51672-2069-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51672-2069-9	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51672-2069-9	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51672-2069-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51672-2069-9	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51672-2069-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51672-2069-9	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51672-2069-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Hydrocortisone Acetate
Brand name suffix: Antipruritic (Anti-Itch)
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE ACETATE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3X7931PO74	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
9f0b09e7-6cfd-4fd6-8631-67799edf4e08	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, Related label table
NDC	Effective	Related label
51672-2069-2	2025-12-05	Hydrocortisone 1% Cream
51672-2069-9	2025-12-05	Hydrocortisone 1% Cream
51672-2069-2	2025-01-30	Hydrocortisone 1% Cream
51672-2069-9	2025-01-30	Hydrocortisone 1% Cream
51672-2069-2	2023-03-31	Hydrocortisone 1% Cream
51672-2069-9	2023-03-31	Hydrocortisone 1% Cream
51672-2069-2	2023-01-30	Hydrocortisone 1% Cream
51672-2069-9	2023-01-30	Hydrocortisone 1% Cream
51672-2069-2	2021-02-05	Hydrocortisone 1% Cream
51672-2069-9	2021-02-05	Hydrocortisone 1% Cream
51672-2069-2	2021-01-29	Hydrocortisone 1% Cream
51672-2069-9	2021-01-29	Hydrocortisone 1% Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-2069-2	Hydrocortisone Acetate Antipruritic (Anti-Itch)	28.4 g in 1 TUBE	CREAM	28.4	9
51672-2069-2	Hydrocortisone Acetate Antipruritic (Anti-Itch)	1 in 1 CARTON	CREAM	1	9
51672-2069-9	Hydrocortisone Acetate Antipruritic (Anti-Itch)	454 g in 1 JAR	CREAM	454	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2069-2	GM - Gram	51672-2069	7e58ef83-9ecb-4754-96e5-7ade9b37c599	1	2012-07-24
51672-2069-9	GM - Gram	51672-2069	31213726-c91a-4798-8489-fd09c97e611f	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydrocortisone Acetate	ACTIVE INGREDIENT	3X7931PO74	HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-2069	HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	5	Current NDC, Legacy NDC, 3 package rows	20230401_9f0b09e7-6cfd-4fd6-8631-67799edf4e08.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 115 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Health Pain Relieving	CAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATE	Natural Essentials, Inc.	f7198485-3d68-41d2-b9b9-f932a0649310	2024-12-04	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE PLUS	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Hisamitsu America, Inc.	364924d3-fac3-4f4e-9b40-decd4ec48245	2024-12-03	Warnings	Exact identifier application number: M017
Bite and Itch	DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE	Weeks & Leo Co., Inc.	0a4d471b-c3f3-0a6a-e063-6394a90ad57b	2024-12-03	Warnings	Exact identifier application number: M017
Menthol	AMISH ORIGINS MEDICATED	Amish Origins LLC	547abe39-3af3-4d70-99dd-caf8d67feda2	2024-12-03	Warnings	Exact identifier application number: M017
Meijer Small Cold-Hot Medicated Patches	MENTHOL	Meijer Distribution Inc	be6012d6-2062-45ba-8fc4-abf14cff5845	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	acdd5622-a9a7-4cc3-877e-57efea23303f	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas DEEP Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu America, Inc.	a4ddb2b9-d023-4c8c-9285-93d51f93207d	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE PLUS	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Hisamitsu America, Inc.	ea5b4a7f-d47d-4dbd-9288-c01329e387e5	2024-12-03	Warnings	Exact identifier application number: M017
Hempvana Ultra Strength Pain Relief - Overnight	LIDOCAINE	Telebrands Corp	1030d478-6805-6579-e063-6294a90a0c76	2024-12-02	Warnings	Exact identifier application number: M017
Campho-Phenique Cold Sore Treatment	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare LLC	106c0bb2-f2e2-4255-867d-d09ff6a5a2e6	2024-12-02	Warnings	Exact identifier application number: M017
Campho-Phenique Antiseptic	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare LLC	82edaef0-0709-4ae1-a664-c9c5adb91ee1	2024-12-02	Warnings	Exact identifier application number: M017
Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll On	THERMACARE CAPSAICIN ROLL ON	Clarion Brands LLC	2850f7e7-41dd-f5f9-e063-6394a90ae519	2024-12-02	Warnings	Exact identifier application number: M017
BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	2ec1cf79-c341-4b79-9047-ce29f0dff419	2024-11-29	Warnings	Exact identifier application number: M017
TheraCare Pain Relieving Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	242204d3-efc7-f7a9-e063-6294a90a5af1	2024-11-27	Warnings	Exact identifier application number: M017
Walgreens Flexible Pain Relieving Lidocaine	LIDOCAINE, MENTHOL	Walgreen Co.	6f070fa3-a61a-4523-a470-ab58bf9400a3	2024-11-27	Warnings	Exact identifier application number: M017
Benadryl Original Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	920c50cb-9bdd-4a36-bb3d-c2559db73327	2024-11-26	Warnings	Exact identifier application number: M017
Universal ARTHRITIS and SPORT	METHYL SALICYLATE, CAPSICUM	Universal Distribution Center LLC	884907a8-c884-4cce-ac10-9d4848fdba3e	2024-11-22	Warnings	Exact identifier application number: M017
Universal ARTHRITIS and SPORT	METHYL SALICYLATE, CAPSICUM	Universal Distribution Center LLC	7f067e95-e01c-4b9a-a02e-0af097beb18c	2024-11-22	Warnings	Exact identifier application number: M017
Universal ARTHRITIS and SPORT	METHYL SALICYLATE, CAPSICUM	Universal Distribution Center LLC	9ece9b3a-0092-4c1c-a913-c2fefcd70541	2024-11-22	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X7931PO74	HYDROCORTISONE ACETATE	50-03-3	HYDROCORTISONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106258	hydrocortisone 1 % Topical Cream	PSN	9f0b09e7-6cfd-4fd6-8631-67799edf4e08	9
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	9f0b09e7-6cfd-4fd6-8631-67799edf4e08	9
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	9f0b09e7-6cfd-4fd6-8631-67799edf4e08	9
106258	hydrocortisone 1 % Topical Cream	SY	9f0b09e7-6cfd-4fd6-8631-67799edf4e08	9
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	9f0b09e7-6cfd-4fd6-8631-67799edf4e08	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-2069-2	51672206902	1 TUBE in 1 CARTON (51672-2069-2) / 28.4 g in 1 TUBE	1 tube	2001-06-01	0000-00-00	No	No	Current
51672-2069-9	51672206909	454 g in 1 JAR (51672-2069-9)	454 g	2001-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone 1% Cream	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-12-02	HUMAN OTC DRUG LABEL	9