CVS HEALTH HEMORRHOIDAL COOLING

Product NDC: 69842-843
Requested package NDC: 69842-843-01
11-digit product format: 698420843
Labeler code: 69842
Product ID: 69842-843_ba6f8a55-3732-42a1-8f49-40c4f05225f0
Type: HUMAN OTC DRUG
Nonproprietary name: PHENYLEPHRINE HYDROCHLORIDE and WITCH HAZEL
Dosage form: GEL
Route: RECTAL
Labeler: CVS
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2004-01-01
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
Active strength: 3 mg/g; mg/g
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69842-843	69842-843-01	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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69842-843-01	2025-01-30	C162847	48780-1	2cef2736-8260-d83d-e063-dadaa90ab31f	CVS HEALTH ™ HEMORRHOIDAL COOLING GEL HEMORRHOIDAL GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69842-843-01	CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL	26 g in 1 TUBE	GEL	26		3
69842-843-01	CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL	1 in 1 CARTON	GEL	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-843	CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND WITCH HAZEL) GEL [CVS]	3	Legacy NDC, 2 package rows	20221123_94e0b160-b557-4f33-8855-345c8b40e9eb.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	94e0b160-b557-4f33-8855-345c8b40e9eb	3
249465	phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal Gel	SCD	94e0b160-b557-4f33-8855-345c8b40e9eb	3
249465	phenylephrine 0.25 % / witch hazel 50 % Rectal Gel	SY	94e0b160-b557-4f33-8855-345c8b40e9eb	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-843-01	69842084301	1 TUBE in 1 CARTON (69842-843-01) > 26 g in 1 TUBE	1 tube	2006-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS HEALTH ™ HEMORRHOIDAL COOLING GEL HEMORRHOIDAL GEL	CVS \| Natureplex LLC	2022-11-18	HUMAN OTC DRUG LABEL	3