Oral Pain Relief

Product NDC: 53943-996
11-digit product format: 539430996
Labeler code: 53943
Product ID: 53943-996_615a4857-a67b-2852-e053-2a91aa0a53ca
Type: HUMAN OTC DRUG
Nonproprietary name: Oral Pain Reliever
Dosage form: GEL
Route: TOPICAL
Labeler: Discount Drug Mart, Inc.
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2015-11-09
Marketing end: 0000-00-00
Substance: BENZOCAINE
Active strength: 200 mg/g
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53943-996-42	2020-09-27	C162847	48780-1	ab0e2407-2dbd-f274-e053-dbdaa90a6471	Drug Facts
53943-996-42	2020-09-25	C162847	48780-1	ab0e2407-2dbd-f274-e053-dbdaa90a6471	Drug Facts
53943-996-42	2020-07-22	C162847	48780-1	ab0e2407-2dbd-f274-e053-dbdaa90a6471	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53943-996-42	Oral Pain Relief	11.9 g in 1 TUBE	GEL	11.9		2
53943-996-42	Oral Pain Relief	1 in 1 CARTON	GEL	1		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	ORAL PAIN RELIEF (ORAL PAIN RELIEVER) GEL [DISCOUNT DRUG MART, INC.]	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	ORAL PAIN RELIEF (ORAL PAIN RELIEVER) GEL [DISCOUNT DRUG MART, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ORAL PAIN RELIEF (ORAL PAIN RELIEVER) GEL [DISCOUNT DRUG MART, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ORAL PAIN RELIEF (ORAL PAIN RELIEVER) GEL [DISCOUNT DRUG MART, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ORAL PAIN RELIEF (ORAL PAIN RELIEVER) GEL [DISCOUNT DRUG MART, INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	ORAL PAIN RELIEF (ORAL PAIN RELIEVER) GEL [DISCOUNT DRUG MART, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-996	ORAL PAIN RELIEF (ORAL PAIN RELIEVER) GEL [DISCOUNT DRUG MART, INC.]	2	Legacy NDC, 2 package rows	20171228_242619de-ebb9-3e4d-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238910	benzocaine 20 % Oral Gel	PSN	242619de-ebb9-3e4d-e054-00144ff88e88	2
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	242619de-ebb9-3e4d-e054-00144ff88e88	2
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	242619de-ebb9-3e4d-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53943-996-42	53943099642	11.9 g in 1 TUBE	11.9 g	Historical