VAGISIL Anti-Itch Medicated Wipes Maximum Strength

Product NDC: 11509-5035
11-digit product format: 115095035
Labeler code: 11509
Product ID: 11509-5035_d52bff6a-9386-4ff7-a2ff-bef4a6ad07f8
Type: HUMAN OTC DRUG
Nonproprietary name: pramoxine hydrochloride
Dosage form: CLOTH
Route: TOPICAL
Labeler: Combe Incorporated
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-06-28
Substance: PRAMOXINE HYDROCHLORIDE
Active strength: 10 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: VAGISIL Anti-Itch Medicated Wipes Maximum Strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1039541	Internal RxNorm lookup
1039550	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
b848f53d-8aea-4efe-aa2c-009d5121fc33	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11509-5035-1	2020-04-21	C162847	48780-1	9d75b9d0-c0eb-f424-e053-dadaa90a57ce	Vagisil Medicated Anti-Itch Wipes Maximum Strength
11509-5035-1	2020-01-31	C162847	48780-1	9d75b9d0-c0eb-f424-e053-dadaa90a57ce	Vagisil Medicated Anti-Itch Wipes Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11509-5035-1	VAGISIL Anti-Itch Medicated Wipes Maximum Strength	4.5 g in 1 PACKET	CLOTH	4.5		9
11509-5035-1	VAGISIL Anti-Itch Medicated Wipes Maximum Strength	12 in 1 CARTON	CLOTH	12		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11509-5035-1	EA - Each	11509-5035	e1c44b32-37dc-49d1-b8c1-d95fe3bdc5e4	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
PRAMOXINE	ACTIVE MOIETY	068X84E056	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
DISODIUM COCOAMPHODIACETATE	INACTIVE INGREDIENT	18L9G3U51M	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
PEG-7 GLYCERYL COCOATE	INACTIVE INGREDIENT	VNX7251543	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
TRIETHANOLAMINE COCOYL GLUTAMATE	INACTIVE INGREDIENT	LA19WH54UL	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11509-5035	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	9	Current NDC, Legacy NDC, 2 package rows	20241211_b848f53d-8aea-4efe-aa2c-009d5121fc33.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 138 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PERSONAL CARE ICE COLD	MENTHOL	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	1994356c-e347-5b7d-e063-6394a90a476c	2024-01-01	Warnings	Exact identifier application number: M017
Dendracin Neurodendraxcin	METHYL SALICYLATE, MENTHOL AND CAPSAICIN	Proficient Rx LP	7e765fc1-74c6-4af3-a9cf-05b57011d7d8	2024-01-01	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Itch Relief Moisturizing	PRAMOXINE HYDROCHLORIDE	L'Oreal USA Products Inc	c6a0880e-fc16-46e9-8314-c56c9d15bf31	2023-12-31	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Anti Itch	HYDROCORTISONE	L'Oreal USA Products Inc.	8d65e945-2557-486f-9279-ecbaa08f31c4	2023-12-31	Warnings	Exact identifier application number: M017
Nighttime Sleep-Aid Non-Habit Forming	DIPHENHYDRAMINE HCI	AptaPharma Inc.	ed0ba7aa-e794-43da-b576-6b9945bf7477	2023-12-30	Warnings	Exact identifier application number: M017
Sting-Kill	BENZOCAINE AND MENTHOL	RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH	b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701	2023-12-29	Warnings	Exact identifier application number: M017
Maybelline New York Baby Lips Dr Rescue Medicated Balm	MENTHOL	L'Oreal USA Products Inc	2f7b8221-66f6-4aed-8359-318cfc656a72	2023-12-28	Warnings	Exact identifier application number: M017
Equate Cortisone	HYDROCORTISONE 1%	Walmart Inc	027fae33-93a0-a61f-e063-6294a90a990f	2023-12-27	Warnings	Exact identifier application number: M017
Walgreens Cool n Heat Lidocaine	LIDOCAINE HCL 4%	Walgreens Co	0681c6c5-5a8b-ea9e-e063-6394a90a83bc	2023-12-27	Warnings	Exact identifier application number: M017
EXTRA STRENGTH WAL-DRYL ITCH RELIEF	DIPHENHYDRAMINE, ZINC ACETATE	WALGREEN CO	681cf1af-2cc3-4e6d-b76f-f00731ea3e12	2023-12-27	Warnings	Exact identifier application number: M017
XRay Pain Relief	MENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATE	Genomma Lab USA	5244ddee-fd9e-4df3-8fb3-b16aa321a316	2023-12-27	Warnings	Exact identifier application number: M017
Camphor Spirit	CAMPHOR 10%	Pharma Nobis, LLC	e42fbe63-b01c-4f85-e053-2a95a90a5143	2023-12-26	Warnings	Exact identifier application number: M017
Equate Calaspray	PRAMOXINE HCL 1%, ZINC ACETATE 0.1%	Walmart Inc	027ed5ab-05ec-569f-e063-6394a90abbc3	2023-12-26	Warnings	Exact identifier application number: M017
EXTERNAL ANALGESIC	CAMPHOR, CAPSICUM, MENTHOL	Hmong 21	3b6155a5-51aa-2780-e054-00144ff8d46c	2023-12-26	Warnings	Exact identifier application number: M017
LEADER Camphor Spirit	CAMPHOR (NATURAL)	Cardinal Health, 110 dba Leader	7d3b0b28-5190-0622-e053-2991aa0af561	2023-12-22	Warnings	Exact identifier application number: M017
Antiseptic Instant Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Pharma Nobis, LLC	e42f484d-a642-3489-e053-2a95a90a4254	2023-12-22	Warnings	Exact identifier application number: M017
Itch Relief Gel	ITCH RELIEF GEL	Pharma Nobis, LLC	e42f484d-a641-3489-e053-2a95a90a4254	2023-12-22	Warnings	Exact identifier application number: M017
Witch Hazel	WITCH HAZEL	Pharma Nobis, LLC	e42f484d-a644-3489-e053-2a95a90a4254	2023-12-22	Warnings	Exact identifier application number: M017
Dermoplast Pain relieving	BENZOCAINE, MENTHOL	Advantice Health	dad00c95-4e11-3eec-e053-2a95a90a7a18	2023-12-21	Warnings	Exact identifier application number: M017
equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesic	LIDOCAINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	bf954949-a7b7-44ba-8565-f1d5c0a6c0d1	2023-12-21	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039541	pramoxine HCl 1 % Medicated Pad	PSN	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039550	Vagisil 1 % Medicated Pad	PSN	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039550	pramoxine hydrochloride 10 MG/ML Medicated Pad [Vagisil Wipes]	SBD	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039541	pramoxine hydrochloride 10 MG/ML Medicated Pad	SCD	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039541	pramoxine hydrochloride 1 % Medicated Pad	SY	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039541	pramoxine hydrochloride 1 % Medicated Wipe	SY	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039550	Vagisil 1 % Medicated Wipes	SY	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039550	Vagisil Wipes 10 MG/ML Medicated Pad	SY	b848f53d-8aea-4efe-aa2c-009d5121fc33	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11509-5035-1	11509503501	12 PACKET in 1 CARTON (11509-5035-1) / 4.5 g in 1 PACKET	12 packet	2005-06-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vagisil Medicated Anti-Itch Wipes Maximum Strength	Combe Incorporated \| Combe Laboratories, Inc.	2024-12-12	HUMAN OTC DRUG LABEL	9