hydrocortisone

Product NDC: 45802-937
11-digit product format: 458020937
Labeler code: 45802
Product ID: 45802-937_509f69b3-52e9-4505-acba-722dee4ebdf1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone
Dosage form: LOTION
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA089074
Marketing category: ANDA
Marketing start: 2008-05-23
Substance: HYDROCORTISONE
Active strength: 25 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A089074-001	STIE-CORT	HYDROCORTISONE	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A089074-001	AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL		RS	1985-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL		RS	1985-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT		1985-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT		1985-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT		1985-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT		1985-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A089074-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089074-001	AT	1	`caaa826d4ba7…`
2025-08-23 18:47 UTC	2025-08	A089074-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089074-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089074-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089074-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089074-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089074-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089074-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089074-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089074-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089074-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089074-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089074-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089074-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089074-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089074-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089074-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089074-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089074-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089074-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089074-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089074-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089074-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089074-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089074-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089074-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089074-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089074-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089074-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089074-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089074-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089074-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089074-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089074-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089074-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089074-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089074-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089074-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089074-001	AT	1	`cb3db0bc1861…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	25 mg/mL

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
197785	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
f05b7fa6-26a9-4aca-8975-819ece891060	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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
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
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
597b1cfd-7b31-5048-62be-ca5cd740da2f	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
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-937-16	hydrocortisone	59 mL in 1 BOTTLE	LOTION	59		10
45802-937-26	hydrocortisone	118 mL in 1 BOTTLE	LOTION	118		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-937-16	ML - Milliliter	45802-937	befd24ee-fcd7-4c5f-bb3b-ff216b80c277	1	2012-07-24
45802-937-26	ML - Milliliter	45802-937	6b7ab7f6-1477-4d80-a034-534ca25144ac	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
DEHYDROACETIC ACID	INACTIVE INGREDIENT	2KAG279R6R	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
MYRISTYL ALCOHOL	INACTIVE INGREDIENT	V42034O9PU	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
MYRISTYL LACTATE	INACTIVE INGREDIENT	1D822OC34X	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE LOTION [PERRIGO NEW YORK INC]	4
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
DEHYDROACETIC ACID	INACTIVE INGREDIENT	2KAG279R6R	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
MYRISTYL ALCOHOL	INACTIVE INGREDIENT	V42034O9PU	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
MYRISTYL LACTATE	INACTIVE INGREDIENT	1D822OC34X	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
POLYOXYL 100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-937	HYDROCORTISONE LOTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]	9	Current NDC, Legacy NDC, 2 package rows	20241222_f05b7fa6-26a9-4aca-8975-819ece891060.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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	8c03671d-28ab-4027-8f5f-d342177ce5f2	2025-10-28	Adverse reactions	Exact identifier application applno (ANDA): 089074 application number: ANDA089074
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	0d85f349-2dc7-44a5-b5bd-83ac78d44d1d	2025-09-24	Adverse reactions	Exact identifier application applno (ANDA): 089074 application number: ANDA089074
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	0cb39a3d-4d3b-4820-b3bd-eff642e08a41	2025-01-28	Adverse reactions	Exact identifier application applno (ANDA): 089074 application number: ANDA089074
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	e64cae82-fd7b-47c8-ada9-4dcb283f1d1f	2024-08-07	Adverse reactions	Exact identifier application applno (ANDA): 089074 application number: ANDA089074
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	a2c18606-631f-4e89-8936-3d635a41c37d	2024-04-03	Adverse reactions	Exact identifier application applno (ANDA): 089074 application number: ANDA089074
hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	f05b7fa6-26a9-4aca-8975-819ece891060	2023-12-31	Adverse reactions	Exact identifier application applno (ANDA): 089074 application number: ANDA089074 ndc (product): 45802-937

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
197785	hydrocortisone 2.5 % Topical Lotion	PSN	0cb39a3d-4d3b-4820-b3bd-eff642e08a41	104
197785	hydrocortisone 2.5 % Topical Lotion	PSN	a2c18606-631f-4e89-8936-3d635a41c37d	104
197785	hydrocortisone 25 MG/ML Topical Lotion	SCD	0cb39a3d-4d3b-4820-b3bd-eff642e08a41	104
197785	hydrocortisone 25 MG/ML Topical Lotion	SCD	a2c18606-631f-4e89-8936-3d635a41c37d	104
197785	hydrocortisone 2.5 % Topical Lotion	SY	0cb39a3d-4d3b-4820-b3bd-eff642e08a41	104
197785	hydrocortisone 2.5 % Topical Lotion	SY	a2c18606-631f-4e89-8936-3d635a41c37d	104
197785	hydrocortisone 2.5 % Topical Lotion	PSN	e64cae82-fd7b-47c8-ada9-4dcb283f1d1f	103
197785	hydrocortisone 25 MG/ML Topical Lotion	SCD	e64cae82-fd7b-47c8-ada9-4dcb283f1d1f	103
197785	hydrocortisone 2.5 % Topical Lotion	SY	e64cae82-fd7b-47c8-ada9-4dcb283f1d1f	103
197785	hydrocortisone 2.5 % Topical Lotion	PSN	0d85f349-2dc7-44a5-b5bd-83ac78d44d1d	102
197785	hydrocortisone 25 MG/ML Topical Lotion	SCD	0d85f349-2dc7-44a5-b5bd-83ac78d44d1d	102
197785	hydrocortisone 2.5 % Topical Lotion	SY	0d85f349-2dc7-44a5-b5bd-83ac78d44d1d	102
197785	hydrocortisone 2.5 % Topical Lotion	PSN	8c03671d-28ab-4027-8f5f-d342177ce5f2	100
197785	hydrocortisone 25 MG/ML Topical Lotion	SCD	8c03671d-28ab-4027-8f5f-d342177ce5f2	100
197785	hydrocortisone 2.5 % Topical Lotion	SY	8c03671d-28ab-4027-8f5f-d342177ce5f2	100
197785	hydrocortisone 2.5 % Topical Lotion	PSN	f05b7fa6-26a9-4aca-8975-819ece891060	10
197785	hydrocortisone 25 MG/ML Topical Lotion	SCD	f05b7fa6-26a9-4aca-8975-819ece891060	10
197785	hydrocortisone 2.5 % Topical Lotion	SY	f05b7fa6-26a9-4aca-8975-819ece891060	10
197785	hydrocortisone 2.5 % Topical Lotion	PSN	5bb45257-cf4e-4760-a1eb-37f27862e806	1
197785	hydrocortisone 25 MG/ML Topical Lotion	SCD	5bb45257-cf4e-4760-a1eb-37f27862e806	1
197785	hydrocortisone 2.5 % Topical Lotion	SY	5bb45257-cf4e-4760-a1eb-37f27862e806	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-937-16	45802093716	59 mL in 1 BOTTLE (45802-937-16)	59 ml	2008-09-24	0000-00-00	No	No	Current
45802-937-26	45802093726	118 mL in 1 BOTTLE (45802-937-26)	118 ml	2008-05-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Lotion USP, 2.5%	Bryant Ranch Prepack	2025-10-28	HUMAN PRESCRIPTION DRUG LABEL	100
Hydrocortisone Lotion USP, 2.5%	Bryant Ranch Prepack	2025-09-24	HUMAN PRESCRIPTION DRUG LABEL	102
Hydrocortisone Lotion USP, 2.5%	Bryant Ranch Prepack	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	104
Hydrocortisone Lotion USP, 2.5%	Bryant Ranch Prepack	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	103
Hydrocortisone Lotion USP, 2.5%	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	104
Hydrocortisone Lotion USP, 2.5%	Padagis Israel Pharmaceuticals Ltd	2023-12-31	HUMAN PRESCRIPTION DRUG LABEL	10
Hydrocortisone - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-03-14	HUMAN PRESCRIPTION DRUG LABEL	1