VAGISIL Anti-Itch Medicated Creme Maximum Strength

Product NDC: 11509-4402
11-digit product format: 115094402
Labeler code: 11509
Product ID: 11509-4402_c2295da1-a600-4d65-98b2-6c81fb08c6c0
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine and Resorcinol
Dosage form: CREAM
Route: TOPICAL
Labeler: Combe Incorporated
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1995-03-01
Substance: BENZOCAINE; RESORCINOL
Active strength: 200; 30 mg/g; mg/g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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 Creme Maximum Strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	200 mg/g
RESORCINOL	30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup
YUL4LO94HK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
637518	Internal RxNorm lookup
1247441	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
bb73ebd7-ceb0-4b54-9e8f-77486d9037fb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11509-4402-1	2020-04-20	C162847	48780-1	9d75b9d0-ed22-f424-e053-dadaa90a57ce	Vagisil Maximum Strength Anti-Itch Creme
11509-4402-1	2020-01-31	C162847	48780-1	9d75b9d0-ed22-f424-e053-dadaa90a57ce	Vagisil Maximum Strength Anti-Itch Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11509-4402-1	VAGISIL Anti-Itch Medicated Creme Maximum Strength	1 in 1 CARTON	CREAM	1		9
11509-4402-1	VAGISIL Anti-Itch Medicated Creme Maximum Strength	28 g in 1 TUBE	CREAM	28		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11509-4402-1	GM - Gram	11509-4402	220844e9-5407-48f4-922a-790ee69a58f4	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
RESORCINOL	ACTIVE INGREDIENT	YUL4LO94HK	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
RESORCINOL	ACTIVE MOIETY	YUL4LO94HK	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	HHT01ZNK31	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
ISOPROPYL STEARATE	INACTIVE INGREDIENT	43253ZW1MZ	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
SODIUM SULFITE	INACTIVE INGREDIENT	VTK01UQK3G	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
TRISODIUM HEDTA	INACTIVE INGREDIENT	K3E0U7O8KI	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11509-4402	VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]	9	Current NDC, Legacy NDC, 2 package rows	20241211_bb73ebd7-ceb0-4b54-9e8f-77486d9037fb.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 44 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine HCI	LIDOCAINE HCI	Trifluent Pharma, LLC	47f7f06b-720e-eeec-e063-6294a90ae823	2026-01-09	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Bellus Medical, LLC	60cb89f6-e326-0773-e053-2a91aa0a33dd	2026-01-09	Warnings	Exact identifier application number: M017
Tetracaine	TETRACAINE	Bellus Medical, LLC	60cabb5f-606b-7a74-e053-2a91aa0ac024	2026-01-09	Warnings	Exact identifier application number: M017
Benzocaine	BENZOCAINE	Bellus Medical, LLC	60cafbaf-8ec6-46a5-e053-2a91aa0af11f	2026-01-09	Warnings	Exact identifier application number: M017
PRAX	PRAMOXINE HYDROCHLORIDE	AvPAK	dc646399-91ba-5cc1-e053-2a95a90a4f9c	2026-01-09	Warnings	Exact identifier application number: M017
2.5% Menthol PAIN RELIEF	MENTHOL	Universal Distribution Center LLC	c842544a-6aea-42af-a77e-7b202371b387	2026-01-09	Warnings	Exact identifier application number: M017
4% Menthol PAIN RELIEF	MENTHOL	Universal Distribution Center LLC	7fb95135-4151-4ef4-bb6d-75251cafff6c	2026-01-09	Warnings	Exact identifier application number: M017
Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Meijer Distribution, Inc	781f89c0-94ab-48de-9e0b-decb37bcde46	2026-01-09	Warnings	Exact identifier application number: M017
LIDOCAINE PAIN RELIEVING Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	2159fb73-cf6c-184a-e063-6394a90a1d14	2026-01-08	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Patch	LIDOCAINE, MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	22d9ce20-1cb6-c5bd-e063-6394a90a9eca	2026-01-08	Warnings	Exact identifier application number: M017
AY BENDITO - THERMOACTIVE	CAMPHOR, MENTHOL	AY BENDITO INT'L THERMO ANALGETICS ROLL-ON	76ef713b-e23d-7b98-e053-2991aa0aad51	2026-01-08	Warnings	Exact identifier application number: M017
AY BENDITO - THERMOACTIVE	CAMPHOR, MENTHOL	AY BENDITO INTERNATIONAL, INC	bbf0ca84-2800-d222-e053-2995a90ad8f3	2026-01-08	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	AvPAK	ef5b0db6-8f0a-4f8e-e053-2995a90a22b7	2026-01-08	Warnings	Exact identifier application number: M017
Capsaicin Topical Analgesic	CAPSAICIN	AvPAK	ef597423-cd01-7324-e053-2a95a90aa1ba	2026-01-08	Warnings	Exact identifier application number: M017
Capsaicin External Analgesic	CAPSAICIN	AvPAK	ef5a3846-1d2f-7023-e053-2a95a90ad716	2026-01-08	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	AvPAK	ef5bb0fa-afc2-62d7-e053-2a95a90a37f4	2026-01-08	Warnings	Exact identifier application number: M017
K2 Cold Therapy	MENTHOL	The Podiatree Co	60dce1ad-125e-396d-e053-2a91aa0a670f	2026-01-08	Warnings	Exact identifier application number: M017
Burn Relief Aloe	LIDOCAINE HCL	Acutens	48c435fe-2670-4b80-bf01-923dc9354422	2026-01-08	Warnings	Exact identifier application number: M017
Relieve A Pain	LIDOCAINE	Relieve A Pain LLC	cafaa830-d894-4590-8928-d579cc791d79	2026-01-08	Warnings	Exact identifier application number: M017
DZUL ARTHRITIS PAIN RELIEF	MENTHOL	Caball Sales, Inc.	159c301c-d462-bb2c-e063-6394a90a9e5a	2026-01-08	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE
YUL4LO94HK	RESORCINOL	108-46-3	RESORCINOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
637518	benzocaine 20 % / resorcinol 3 % Vaginal Cream	PSN	bb73ebd7-ceb0-4b54-9e8f-77486d9037fb	9
1247441	Vagisil Maximum Strength 20 % / 3 % Vaginal Cream	PSN	bb73ebd7-ceb0-4b54-9e8f-77486d9037fb	9
1247441	benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal Cream [Vagisil Original Formula]	SBD	bb73ebd7-ceb0-4b54-9e8f-77486d9037fb	9
637518	benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal Cream	SCD	bb73ebd7-ceb0-4b54-9e8f-77486d9037fb	9
637518	benzocaine 20 % / resorcinol 3 % Vaginal Cream	SY	bb73ebd7-ceb0-4b54-9e8f-77486d9037fb	9
1247441	Vagisil Maximum Strength (benzocaine 20 % / resorcinol 3 % ) Vaginal Cream	SY	bb73ebd7-ceb0-4b54-9e8f-77486d9037fb	9
1247441	Vagisil, Maximum Strength, Anti-Itch Topical Cream	SY	bb73ebd7-ceb0-4b54-9e8f-77486d9037fb	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11509-4402-1	11509440201	1 TUBE in 1 CARTON (11509-4402-1) / 28 g in 1 TUBE	1 tube	1995-03-01	0000-00-00	No	No	Current