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 19 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biofreeze Menthol	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	3f2b1f48-2d78-4985-a046-9f72de5e1a9b	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze	MENTHOL	Reckitt Benckiser LLC	10a8face-47da-ebbe-e063-6294a90a42fe	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Foot Cream	MENTHOL	Reckitt Benckiser LLC	32450cbf-4ed4-402b-a30e-e08a17bba3fb	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze	MENTHOL	Reckitt Benckiser LLC	a227213b-e89f-7144-e053-2a95a90a7e74	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze	MENTHOL	Reckitt Benckiser LLC	00bb462a-27d0-6f74-e063-6394a90a90ec	2026-05-13	Warnings	Exact identifier application number: M017
BioFreeze Dry Stick	MENTHOL	Reckitt Benckiser LLC	26d62cd2-9209-8cca-e063-6394a90a2028	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Foot Pain Relief Set	MENTHOL	Reckitt Benckiser LLC	4a885eef-0364-4655-bccc-7158c76cc5b2	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Colorless Roll-On	MENTHOL	Reckitt Benckiser LLC	a8d59d45-0e85-43d1-affd-bbe922c4acb1	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Colorless	MENTHOL	Reckitt Benckiser LLC	939dbbc3-71ec-4990-840e-7c9b8d430562	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Flexible Relief Strip	MENTHOL	Reckitt Benckiser LLC	6ec26bae-e395-49aa-969e-8c653d6f0b27	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Day and Overnight	MENTHOL	Reckitt Benckiser LLC	fb5c8f89-a720-ad32-e053-6294a90a2abe	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Foam	MENTHOL	Reckitt Benckiser LLC	890191e8-99ad-489c-8f21-2592f3d31936	2026-05-13	Warnings	Exact identifier application number: M017
Orajel Cold Sore Touch Free - Single Dose	BENZALKONIUM CHLORIDE, BENZOCAINE	Church & Dwight Co., Inc.	ce40829e-941f-2548-e053-2995a90a1e0e	2026-05-13	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Patch	LIDOCAINE	GERI-CARE PHARMACEUTICAL CORP	51b7753b-8619-6ea9-e063-6294a90a4ea4	2026-05-13	Warnings	Exact identifier application number: M017
DERMFREE Anti-itch Cream	HYDROCORTISONE1% ANTI-ITCH CREAM	Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.	519c319a-9c43-0e63-e063-6394a90ab869	2026-05-13	Warnings	Exact identifier application number: M017
Valtrum TOPICAL ANALGESIC	CAMPHOR, MENTHOL, METHYL SALICYLATE	Laboratorios Quantium LLC	f3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Professional Colorless	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser	4639201c-a67a-475f-8df6-3dc6225803ad	2026-05-12	Warnings	Exact identifier application number: M017
Biofreeze Professional Colorless Roll-On	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	bae9946a-4c68-4759-9fb3-0a61a7ad0eb7	2026-05-12	Warnings	Exact identifier application number: M017
Instaflex Pain Relief Cream	MENTHOL	Healthy Directions, LLC	665b847a-9cfb-49fc-975b-81c97f936575	2026-05-12	Warnings	Exact identifier application number: M017
Theracare Cold Therapy Pain Relief	MENTHOL	Veridian Healthcare	51a5a043-07b6-1c96-e063-6394a90aa926	2026-05-12	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