Americaine

Product NDC: 63736-375
11-digit product format: 637360375
Labeler code: 63736
Product ID: 63736-375_5dbb80f4-3570-183f-e063-6294a90a3b34
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Insight Pharmaceuticals LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-07-10
Marketing end: 2028-03-31
Substance: BENZOCAINE
Active strength: 5.6 g/28g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
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: Americaine

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	5.6 g/28g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63736-375-01	Americaine	28 g in 1 TUBE	OINTMENT	28		6
63736-375-01	Americaine	1 in 1 BOX	OINTMENT	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63736-375-01	GM - Gram	63736-375	509a3589-ef43-4500-b39d-108301136633	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	AMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS]	1
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	AMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS]	1
Benzethonium Chloride	INACTIVE INGREDIENT	PH41D05744	AMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS]	1
Polyethylene glycol 300	INACTIVE INGREDIENT	5655G9Y8AQ	AMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS]	1
Polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	AMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63736-375	AMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS LLC]	5	Current NDC, Legacy NDC, 2 package rows	20241129_d13c022f-2f91-40b4-bd66-0cfc0e147a5f.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 18 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hemorrhoid Pain Relief	LIDOCAINE	Telebrands Corp	04164425-ca3b-ef24-e063-6294a90a59d8	2024-11-20	Warnings	Exact identifier application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic	LIDOCAINE	Telebrands Corp	f525075a-d7ee-dad0-e053-2a95a90a6f3f	2024-11-20	Warnings	Exact identifier application number: M015
Curist Lidocaine Numbing Relief	LIDOCAINE	Little Pharma, Inc.	bff3c422-a0df-6196-e053-2a95a90af033	2024-11-20	Warnings	Exact identifier application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinum	LIDOCAINE 5%	Telebrands Corp	2774ec41-7366-ac8c-e063-6394a90a1ee2	2024-11-20	Warnings	Exact identifier application number: M015
Walgreens Anorectal Lidocaine Cream	5% LIDOCAINE	Walgreens Company	3052fac7-fd68-43f4-9950-8c07288a6b6d	2024-11-20	Warnings	Exact identifier application number: M015
Lidocaine Anorectal	LIDOCAINE	Patrin Pharma, Inc	456d41fe-8449-4980-9291-d7a3b65a900d	2024-11-13	Warnings	Exact identifier application number: M015
MyDerm	PENYLEPHRINE HCI, WITCH HAZEL, LIDOCAINE HCL,	Inspec Solution LLC.	2618eba1-9308-a666-e063-6394a90ac3d2	2024-11-04	Warnings	Exact identifier application number: M015
Granulotion Medicated	MENTHOL, ZINC OXIDE	GL HEALTH, INC.	01701780-b160-415b-b34d-362237179475	2024-10-29	Warnings	Exact identifier application number: M015
rexall hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Dolgencorp Inc	0415c51b-5a12-49d4-8968-0131ddb85545	2024-10-23	Warnings	Exact identifier application number: M015
Exchange Select Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Army & Air Force Exchange Service	8155ed74-9412-498f-998c-4a29c46e934f	2024-10-23	Warnings	Exact identifier application number: M015
Leader Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	c4814524-0f4c-4351-a431-5b4b6431fd28	2024-10-23	Warnings	Exact identifier application number: M015
basic care hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Amazon.com Services LLC	617d9213-31f0-4c71-be0c-7961b96e5143	2024-10-23	Warnings	Exact identifier application number: M015
Signature Care Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Safeway	e74b71a1-915d-4e5b-b548-d5cce7945dbd	2024-10-23	Warnings	Exact identifier application number: M015
Equaline Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	d29b7824-ff9e-4875-b3de-92721c8add0e	2024-10-23	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Publix Super Markets Inc	a241cb37-7007-4fd8-a12e-f3fc6d6f780e	2024-10-22	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Kroger Company	d44ca22a-dc20-454d-99aa-403a8c7a3e00	2024-10-22	Warnings	Exact identifier application number: M015
rugby hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Rugby Laboratories	c1a126b5-0d34-437f-a7ef-8d5cbeb7b03b	2024-10-22	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Meijer Distribution Inc	1431397e-3515-4794-a494-70667948e14c	2024-10-18	Warnings	Exact identifier application number: M015
signature care hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Safeway	afcf68cf-f187-44d3-ad91-b1e79b182bc6	2024-10-17	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	H E B	1435432d-5ff2-468b-808d-fb0c99a0717b	2024-10-17	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1426293	Americaine Hemorrhoidal 20 % Topical Ointment	PSN	d13c022f-2f91-40b4-bd66-0cfc0e147a5f	6
244557	benzocaine 20 % Topical Ointment	PSN	d13c022f-2f91-40b4-bd66-0cfc0e147a5f	6
1426293	benzocaine 0.2 MG/MG Topical Ointment [Americaine Hemorrhoidal]	SBD	d13c022f-2f91-40b4-bd66-0cfc0e147a5f	6
244557	benzocaine 0.2 MG/MG Topical Ointment	SCD	d13c022f-2f91-40b4-bd66-0cfc0e147a5f	6
1426293	Americaine Hemorrhoidal 0.2 MG/MG Topical Ointment	SY	d13c022f-2f91-40b4-bd66-0cfc0e147a5f	6
1426293	Americaine Hemorrhoidal 20 % Topical Ointment	SY	d13c022f-2f91-40b4-bd66-0cfc0e147a5f	6
244557	benzocaine 20 % Topical Ointment	SY	d13c022f-2f91-40b4-bd66-0cfc0e147a5f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63736-375-01	63736037501	1 TUBE in 1 BOX (63736-375-01) / 28 g in 1 TUBE	1 tube	2009-07-10	2028-03-31	No	No	Current