Proctofoam

Product NDC: 21695-982
11-digit product format: 216950982
Labeler code: 21695
Product ID: 21695-982_14e43813-665c-4cef-b3b1-60eafc880f41
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone acetate and pramoxine hydrochloride
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: Rebel Distributors Corp
Application: ANDA086195
Marketing category: ANDA
Marketing start: 1978-07-26
Marketing end: 0000-00-00
Substance: HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength: 100 mg/10g; mg/10g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-982		I	Inactivated by FDA		2026-08-03
excluded package	package	21695-982	21695-982-10	I	Inactivated by FDA		2026-08-03

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 · 44 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-982-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-982-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-982-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-982-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-982-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-982-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-982-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-982-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-982-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-982-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-982-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-982-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-982-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-982-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-982-10	`1332a3947898…`	`d4bfe170f9cd…`
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	21695-982-10	`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	21695-982-10	`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	21695-982-10	`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	21695-982-10	`8dfbde2a14a4…`	`c9ff85d89658…`
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	21695-982-10	`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	21695-982-10	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-982-10	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A086195-001	PROCTOFOAM HC	HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086195-001	BX

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086195-001	PROCTOFOAM HC	1%;1%	AEROSOL, METERED / TOPICAL	BX	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086195-001	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086195-001	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086195-001	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086195-001	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086195-001	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086195-001	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086195-001	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086195-001	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086195-001	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086195-001	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086195-001	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086195-001	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086195-001	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086195-001	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086195-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086195-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086195-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086195-001	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086195-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086195-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086195-001	BX	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086195-001	BX	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086195-001	BX	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086195-001	BX	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086195-001	BX	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086195-001	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086195-001	BX	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086195-001	BX	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086195-001	BX	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086195-001	BX	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086195-001	BX	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086195-001	BX	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086195-001	BX	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086195-001	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086195-001	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086195-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086195-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086195-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086195-001	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086195-001	BX	1	`cb3db0bc1861…`

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
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02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
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36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
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705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
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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
21695-982-10	2019-09-24	C162847	48780-1	934fe258-4ad9-48b1-e053-8cdaa90a720a	proctofoam ® HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-982-10	ProctofoamHC	1 in 1 CARTON	AEROSOL, FOAM	1		1
21695-982-10	ProctofoamHC	10 g in 1 CONTAINER	AEROSOL, FOAM	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-982-10	GM - Gram	21695-982	bc068676-88b6-4b5a-877e-617c045c27c4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
hydrocortisone acetate	ACTIVE INGREDIENT	3X7931PO74	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1
pramoxine hydrochloride	ACTIVE INGREDIENT	88AYB867L5	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1
hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1
pramoxine	ACTIVE MOIETY	068X84E056	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1
isobutane	INACTIVE INGREDIENT	BXR49TP611	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1
propane	INACTIVE INGREDIENT	T75W9911L6	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-982	PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20111118_14e43813-665c-4cef-b3b1-60eafc880f41.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCTOFOAM HC	PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE	Viatris Specialty LLC	3831e931-ec0a-11e3-ac10-0800200c9a66	2025-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086195 application number: ANDA086195

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X7931PO74	HYDROCORTISONE ACETATE	50-03-3	HYDROCORTISONE ACETATE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
828362	hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal Foam	PSN	14e43813-665c-4cef-b3b1-60eafc880f41	1
828364	proctofoam-HC 1 % / 1 % Rectal Foam	PSN	14e43813-665c-4cef-b3b1-60eafc880f41	1
828364	hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Foam [Proctofoam-HC]	SBD	14e43813-665c-4cef-b3b1-60eafc880f41	1
828362	hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Foam	SCD	14e43813-665c-4cef-b3b1-60eafc880f41	1
828362	hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal Foam	SY	14e43813-665c-4cef-b3b1-60eafc880f41	1
828364	Proctofoam-HC (hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % ) Rectal Foam	SY	14e43813-665c-4cef-b3b1-60eafc880f41	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-982-10	21695098210	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
proctofoam ® HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%)	Rebel Distributors Corp	2011-09-13	HUMAN PRESCRIPTION DRUG LABEL	1