Hemorrhoidal Cooling Gel

Product NDC: 24385-421
11-digit product format: 243850421
Labeler code: 24385
Product ID: 24385-421_ba83b1fe-23a3-4673-8b31-e47d02cf1cd7
Type: HUMAN OTC DRUG
Nonproprietary name: phenylephrine and witch hazel
Dosage form: GEL
Route: TOPICAL
Labeler: Amerisource Bergen
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2006-08-01
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
Active strength: 0 g/g; g/g
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	24385-421		I	Inactivated by FDA		2026-10-15
excluded package	package	24385-421	24385-421-06	I	Inactivated by FDA		2026-10-15

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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`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	24385-421-06	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24385-421-06	2019-10-21	C162847	48780-1	956f9ecf-dcb9-621f-e053-dbdaa90a74ad	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24385-421-06	Hemorrhoidal Cooling Gel	1 in 1 BOX	GEL	1		1
24385-421-06	Hemorrhoidal Cooling Gel	26 g in 1 TUBE	GEL	26		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24385-421-06	GM - Gram	24385-421	0c174c9b-6c82-4bea-a163-9f3c211d71be	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
WITCH HAZEL	ACTIVE INGREDIENT	101I4J0U34	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
WITCH HAZEL	ACTIVE MOIETY	101I4J0U34	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
SULISOBENZONE	INACTIVE INGREDIENT	1W6L629B4K	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24385-421	HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [AMERISOURCE BERGEN]	1	Legacy NDC, 2 package rows	20100105_ca59ecb1-2a80-41f3-a0c8-816e1590c611.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
101I4J0U34	WITCH HAZEL		WITCH HAZEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
249465	phenylephrine HCl 0.25 % / witch hazel 50 % Rectal Gel	PSN	ca59ecb1-2a80-41f3-a0c8-816e1590c611	1
249465	phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal Gel	SCD	ca59ecb1-2a80-41f3-a0c8-816e1590c611	1
249465	phenylephrine 0.25 % / witch hazel 50 % Rectal Gel	SY	ca59ecb1-2a80-41f3-a0c8-816e1590c611	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
24385-421-06	24385042106	1 in 1 BOX	Historical