HYDROCORTISONE

Product NDC: 50332-0042
11-digit product format: 503320042
Labeler code: 50332
Product ID: 50332-0042_25d82d74-ad85-4285-b25d-dbd59d7bdb1e
Type: HUMAN OTC DRUG
Nonproprietary name: HYDROCORTISONE ACETATE
Dosage form: CREAM
Route: TOPICAL
Labeler: HART Health
Application: M
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1974-01-01
Substance: HYDROCORTISONE ACETATE
Active strength: 10 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 16 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
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50332-0042-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50332-0042-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50332-0042-4	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50332-0042-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50332-0042-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50332-0042-4	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50332-0042-1	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50332-0042-2	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50332-0042-4	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50332-0042-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50332-0042-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50332-0042-4	`8dfbde2a14a4…`	`c9ff85d89658…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE ACETATE	10 mg/g

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
1043690	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
779f945f-ab69-40de-8d86-ab76debc5c7c	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
50332-0042-1	2024-02-15	HYDROCORTISONE CREAM
50332-0042-2	2024-02-15	HYDROCORTISONE CREAM
50332-0042-4	2024-02-15	HYDROCORTISONE CREAM
50332-0042-1	2024-01-30	HYDROCORTISONE CREAM
50332-0042-2	2024-01-30	HYDROCORTISONE CREAM
50332-0042-4	2024-01-30	HYDROCORTISONE CREAM
50332-0042-1	2022-11-28	HYDROCORTISONE CREAM
50332-0042-2	2022-11-28	HYDROCORTISONE CREAM
50332-0042-4	2022-11-28	HYDROCORTISONE CREAM
50332-0042-1	2021-01-29	HYDROCORTISONE CREAM
50332-0042-2	2021-01-29	HYDROCORTISONE CREAM
50332-0042-4	2021-01-29	HYDROCORTISONE CREAM

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE ACETATE	ACTIVE INGREDIENT	3X7931PO74	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
CITRIC ACID ACETATE	INACTIVE INGREDIENT	DSO12WL7AU	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50332-0042	HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [HART HEALTH]	5	Current NDC, Legacy NDC	20240217_779f945f-ab69-40de-8d86-ab76debc5c7c.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 4 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Street Antibacterial Liquid Hand	BENZALKONIUM CHLORIDE	Amerifoods Trading Company	e9d5fefa-970b-42ba-8139-18e564415344	2025-11-06	Warnings	Exact identifier application number: M
Cetirza	CETIRIZINE HCL	HART Health	44b22f6f-5731-4dfe-af33-4e4e54fc3af5	2025-10-06	Warnings	Exact identifier application number: M
Dolce and Gabbana Blueberry Nutri Tint SPF 20 6W Light	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	d2930d0e-c622-4843-87f2-fa1a92837ff2	2025-09-05	Warnings	Exact identifier application number: M
Alcohol	ISOPROPYL ALCOHOL	NorMed	959815e5-a73b-4905-9d7d-904b33498386	2025-08-15	Warnings	Exact identifier application number: M
TRIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	HART Health	c1903b9f-390a-4756-800c-fd93be4182e3	2025-08-13	Warnings, Adverse reactions	Exact identifier application number: M
THERASTAT	CHERRY COUGH DROPS	HART Health	96bae19a-3337-4199-9b8c-cdf9b368178b	2025-08-04	Warnings	Exact identifier application number: M
Docu Liquid	DOCUSATE SODIUM	ATLANTIC BIOLOGICALS CORP.	f4ed0721-3be9-4108-a6c9-dbbe115249e9	2025-07-31	Warnings	Exact identifier application number: M
MINTOX MAXIMUM STRENGTH	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	ATLANTIC BIOLOGICALS CORP.	ac6a47e7-972f-4b82-96da-89926d345e9f	2025-07-31	Warnings	Exact identifier application number: M
SENNA	SENNA	ATLANTIC BIOLOGICALS CORP.	8b7cc0d5-029b-43f7-a050-8771e7db4551	2025-07-31	Warnings	Exact identifier application number: M
Stimulant Laxative Plus Stool Softener	DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG	ATLANTIC BIOLOGICALS CORP.	4c02fcec-6bb7-4497-96c5-0d809209dd17	2025-06-27	Warnings	Exact identifier application number: M
Orythia Pain Relieving Lidocaine	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	d658d495-dd2c-40b7-9446-6f10040ed55e	2025-06-27	Warnings	Exact identifier application number: M
Bonica EaseX Pain Relieving	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	Planet (Anhui) Pharmaceutical Co., Ltd.	34f1196a-fda1-4bef-be71-e5a09ee97bc1	2025-06-27	Warnings	Exact identifier application number: M
Regular Strength Enteric coated aspirin	ASPIRIN	ATLANTIC BIOLOGICALS CORP.	e1c8d0ed-da1d-4b1a-9a85-7b8532775f87	2025-06-24	Warnings	Exact identifier application number: M
Aspirin Low Dose Chewable Orange	ASPIRIN	ATLANTIC BIOLOGICALS CORP.	a0d8ee59-1ce0-4ddd-a90c-54adb512540c	2025-06-24	Warnings	Exact identifier application number: M
Hydrogen Peroxide	HYDROGEN PEROXIDE	HART Health	f50af223-ba83-458a-a557-1ba5dc221a9c	2025-06-10	Warnings	Exact identifier application number: M
Pharbetol Regular strength	ACETAMINOPHEN	ATLANTIC BIOLOGICALS CORP.	05a91d24-b498-4ba2-a275-68b871cf62d2	2025-06-05	Warnings	Exact identifier application number: M
TEENY TUMMY Gas Relief Drops	SIMETHICONE	ATLANTIC BIOLOGICALS CORP	376660a2-becb-48cf-a9f5-6a76a8b8ca70	2025-05-30	Warnings	Exact identifier application number: M
Mineral Oil	MINERAL OIL	ATLANTIC BIOLOGICALS CORP.	960502ae-2468-406e-8799-cacb01f2727e	2025-05-23	Warnings	Exact identifier application number: M
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	ATLANTIC BIOLOGICALS CORP.	5c02d0ba-91e4-4bd2-ac66-6905323653b2	2025-05-12	Warnings	Exact identifier application number: M
MAX Tussin Cough and Chest Congestion DM Sugar Free	DEXTROMETHORPHAN HBR, GUAIFENESIN	ATLANTIC BIOLOGICALS CORP.	8f496c61-41a6-41ba-80f5-7a5309c4d18b	2025-05-12	Warnings	Exact identifier application number: M

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
1043690	hydrocortisone acetate 1 % Topical Cream	PSN	779f945f-ab69-40de-8d86-ab76debc5c7c	5
1043690	hydrocortisone acetate 10 MG/ML Topical Cream	SCD	779f945f-ab69-40de-8d86-ab76debc5c7c	5
1043690	hydrocortisone acetate 1 % Topical Cream	SY	779f945f-ab69-40de-8d86-ab76debc5c7c	5
1043690	hydrocortisone acetate 1 % Topical Cream	PSN	a584d3ad-9a00-4acc-bf73-6a3cd509b053	1
1043690	hydrocortisone acetate 10 MG/ML Topical Cream	SCD	a584d3ad-9a00-4acc-bf73-6a3cd509b053	1
1043690	hydrocortisone acetate 1 % Topical Cream	SY	a584d3ad-9a00-4acc-bf73-6a3cd509b053	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50332-0042-1	50332004201	10 PACKET in 1 BOX, UNIT-DOSE (50332-0042-1) / .9 g in 1 PACKET	10 packet	1974-01-01	0000-00-00	No	No	Current
50332-0042-2	50332004202	25 PACKET in 1 BOX, UNIT-DOSE (50332-0042-2) / .9 g in 1 PACKET	25 packet	1974-01-01	0000-00-00	No	No	Current
50332-0042-4	50332004204	144 PACKET in 1 BOX, UNIT-DOSE (50332-0042-4) / .9 g in 1 PACKET	144 packet	1974-01-01	0000-00-00	No	No	Current
50332-0042-7	50332004207	10 PACKET in 1 BAG (50332-0042-7) / .9 g in 1 PACKET	10 packet	2000-01-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCORTISONE CREAM	HART Health	2024-02-16	HUMAN OTC DRUG LABEL	5
HYDROCORTISONE CREAM	A-S Medication Solutions	2019-10-14	HUMAN OTC DRUG LABEL	1