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 66 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCORTISONE	HYDROCORTISONE	Encube Ethicals, Inc.	969cd576-82d3-4662-bbc1-3587a1f6a564	2025-11-10	Warnings	Exact identifier application number: M017
Jelcaine Sterile	LIDOCAINE HCL JELLY USP, 2%	Brookfield Pharmaceuticals, LLC	1a39d1de-7aa2-3068-e063-6394a90aed85	2025-11-10	Warnings	Exact identifier application number: M017
Hush Anesthetic	LIDOCAINE	HUSH Anesthetic	c6e86a0f-6f9b-45b7-86ce-0bb1c198061a	2025-11-10	Warnings	Exact identifier application number: M017
Hush Anesthetic	LIDOCAINE	HUSH Anesthetic	97ae1993-7268-4b7f-92e2-6004337d5650	2025-11-10	Warnings	Exact identifier application number: M017
MENTHOL AND METHYL SALICYLATE	ELECTRIC MEDICATED BALM ULTRA STRENGTH	FEI FAH MEDICAL MANUFACTURING PTE LTD	91e6d3b9-25bb-4015-9d96-bd27f93e5ada	2025-11-10	Warnings	Exact identifier application number: M017
E MEI SHAN MEDICATED	CAMPHOR, MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	bda1e7c1-42df-4126-a512-80f843b07fd0	2025-11-10	Warnings	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVING	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	9850754b-ac94-4ec6-b75a-8096e5ac9456	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
TONG FENG DING PAIN RELIEF	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	fe87b864-b3ee-4a4b-8e5a-e1ee6493de0d	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	5ef90782-8201-47d1-b57f-f032d4c9b06a	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	1388ab3a-c26f-427d-898d-0d88411a5fba	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Capsaicin Patch Hot	CAPSAICIN	MADISON ONE ACME INC	f74db6e0-853a-4eb3-a4b5-9da2cd3d95cf	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Lung Choy Shung Pain Relief Liquid	MENTHOL AND CAMPHOR	MADISON ONE ACME INC	4842c6ec-7823-4f6b-afc4-258fce2c2391	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
701 DIEDA ZHENGTONG YAOGAO MEDICATED	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	115041ff-5046-4ca4-b54b-5652037e74bd	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEF	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	0f269a41-4b56-4e22-b9cb-17d99bf76a57	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
ZANG HONG HUA PAIN RELIEVING	CAMPHOR, CAPSAICIN, AND METHYL SALICYLATE	MADISON ONE ACME INC	e0a8811c-07cf-4dee-a0e5-13b8af1b27b6	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
NECK AND LUMBAR PAIN RELIEVING BALM	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	d06f0650-a5f6-4bc1-a70b-b0fc16968fa9	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
SHU JIN HUO LUO PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	ccb6740d-3399-4a2b-ae65-15ca557ba83b	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
GuruNanda Pain Relief	LIDOCAINE HYDROCHLORIDE	GuruNanda, LLC.	3ab6a133-8dca-e14e-e063-6394a90a85e7	2025-11-10	Warnings	Exact identifier application number: M017
HUO LUO PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	65581716-5a2c-4ee8-816d-00caed7b95b4	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
JOSEPHS LION PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e	2025-11-10	Warnings, Adverse reactions	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