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 99 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone with aloe	HYDROCORTISONE	Encube Ethicals, Inc.	12a1774d-a97e-4787-b6b1-8e8cd40b7b70	2025-02-26	Warnings	Exact identifier application number: M017
Thera Plus Maximum Strength Feminine Anti-Itch	BENZOCAINE, RESORCINOL	FOURSTAR GROUP USA, INC.	0007e3ea-882b-4000-8e70-2bcec2c08613	2025-02-26	Warnings	Exact identifier application number: M017
Tattoo numbing cream	LIDOCAINE	BLOOMWELL GARDENS LLC	2ea9d34e-408d-f8d6-e063-6394a90a72a4	2025-02-26	Warnings	Exact identifier application number: M017
Icy Hot Pro No-Mess	CAMPHOR, MENTHOL	Chattem, Inc.	9e8fedf5-fb59-4531-b288-715f851ee05b	2025-02-26	Warnings	Exact identifier application number: M017
Family Wellness Max Strength 1 Hydrocortisone Cream	HYDROCORTISONE	Family Dollar Stores, Inc	bca5ac2c-45cd-44e3-98f1-317a04e44d7d	2025-02-25	Warnings	Exact identifier application number: M017
Tylenol Precise Nighttime Pain Relieving	CAMPHOR, MENTHOL	Kenvue Brands LLC	2ef4fe16-0820-6aad-e063-6294a90a8449	2025-02-25	Warnings	Exact identifier application number: M017
LidoPro Pain Relief	CAPSAICIN AND LIDOCAINE	Preferred Pharmaceuticals Inc.	c259ef92-5d07-4590-adf1-3a106333eee0	2025-02-21	Warnings	Exact identifier application number: M017
Cortizone 10 Ultra Soothing Itch Relief	HYDROCORTISONE	Chattem, Inc.	8a9e2d32-a65f-4253-8041-4146f4e3b738	2025-02-21	Warnings	Exact identifier application number: M017
AVCOO Pain Relief Roll On	MENTHOL	ADP Health Limited	420d8cdc-f47f-4d33-bf25-9033ff266c49	2025-02-19	Warnings	Exact identifier application number: M017
AVCOO Pain Relief	MENTHOL	ADP Health Limited	700ce2cf-749e-40be-91c3-850d9b2168ca	2025-02-19	Warnings	Exact identifier application number: M017
Sunburn Relief Gel	LIDOCAINE HCL	Jell Pharmaceuticals Pvt. Ltd	2e7c49de-5438-4858-e063-6294a90ad98c	2025-02-19	Warnings	Exact identifier application number: M017
VTROUY Tattoo Numbing Cream	TATTOO NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	2e899851-b3cd-0758-e063-6294a90afea8	2025-02-19	Warnings	Exact identifier application number: M017
Pomada Dragon Pain Relief	MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATE	Genomma Lab USA	9d98f48b-6d88-4df9-9459-7cf7ba5de044	2025-02-19	Warnings	Exact identifier application number: M017
Pain Relieving Cream	HISTAMINE DIHYDROCHLORIDE	Mediapower, Inc. DBA Dr Newton's And Naturals	9eeea033-ae87-4d83-85d0-b8fa653a0806	2025-02-19	Warnings	Exact identifier application number: M017
Sure Complete Confidence Antiperspirant Deodorant Aerosol, Regular	ALUMINUM CHLOROHYDRATE	Sodalis USA, LLC	7839cf53-dbd2-4dbb-a309-1581d51f8adc	2025-02-18	Warnings	Exact identifier application number: M017
CANNA NUMB Roll On	LIDOCAINE HYDROCHLORIDE, MENTHOL	Cannanumb LLC	c1eb0348-3b0e-4f1c-a46b-1ff4aa165fb4	2025-02-17	Warnings	Exact identifier application number: M017
Vaporizing Chest Rub 4 oz.	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rejoice International Inc.	7173b141-123e-6cd4-e053-2a95a90a8600	2025-02-12	Warnings	Exact identifier application number: M017
Vaporizing Chest Rub 4 oz. 3 pk	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rejoice International Inc.	71c186a1-8283-2482-e053-2995a90acc1f	2025-02-12	Warnings	Exact identifier application number: M017
Roman Swipes	BENZOCAINE	Roman Health Ventures Inc.	7f0eac8c-7235-99d8-e053-2a91aa0a634e	2025-02-12	Warnings	Exact identifier application number: M017
SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOR	EVI LABS	EVI LABS	2df7658d-83d3-41ac-e063-6294a90ab1dd	2025-02-12	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