Quality Choice Maximum Strength Oral Pain Relieving

Product NDC: 63868-953
11-digit product format: 638680953
Labeler code: 63868
Product ID: 63868-953_41629205-ee47-326e-e063-6294a90ab1ec
Type: HUMAN OTC DRUG
Nonproprietary name: BENZOCAINE
Dosage form: GEL
Route: TOPICAL
Labeler: Chain Drug Marketing Association Inc
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-05-31
Substance: BENZOCAINE
Active strength: 20 g/100g
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: Quality Choice Maximum Strength Oral Pain Relieving
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	20 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238910	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
dbde8e7f-85d8-4083-b01a-3a7e410a7747	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-02-07	QC Maximum Strength Oral Analgesic 0.42oz 95362
2025-02-07	QC Maximum Strength Oral Analgesic 0.42oz 95362
2022-03-31	QC Maximum Strength Oral Analgesic 0.42oz 95362
2022-03-31	QC Maximum Strength Oral Analgesic 0.42oz 95362
2022-01-28	QC Maximum Strength Oral Analgesic 0.42oz 95362
2022-01-28	QC Maximum Strength Oral Analgesic 0.42oz 95362

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-953-11	Quality Choice Maximum Strength Oral Pain Relieving	11.76 g in 1 TUBE	GEL	11.76		11
63868-953-11	Quality Choice Maximum Strength Oral Pain Relieving	1 in 1 CARTON	GEL	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-953-11	GM - Gram	63868-953	6f58de23-8df3-45da-8133-3a43ded309c6	1	2023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-953	QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]	10	Current NDC, Legacy NDC, 2 package rows	20250210_dbde8e7f-85d8-4083-b01a-3a7e410a7747.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 2 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-25	Warnings	Exact identifier application number: M022
Ludens Watermelon Throat Drops	PECTIN	Prestige Brands Holdings, Inc.	adfb248a-96bb-4742-9df6-c47edccdd671	2026-08-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	584b38ce-d1ef-4ecc-a887-7c96e7f9669f	2026-08-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Walgreens	fb93c7f6-e025-4cf2-9997-acfe9a0debdd	2026-08-19	Warnings	Exact identifier application number: M022
CVS Saline	NASAL	CVS PHARMACY	f02c41b0-c78e-41cd-aa4a-2756bbe92087	2026-08-19	Warnings	Exact identifier application number: M022
Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	5965eb2a-1261-5258-e063-6294a90a7c2d	2026-08-19	Warnings	Exact identifier application number: M022
Ludens Honey Licorice Throat Drops	MENTHOL	Prestige Brands Holdings, Inc.	5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac	2026-08-19	Warnings	Exact identifier application number: M022
Ludens Dual Relief	PECTIN AND MENTHOL	Prestige Brands Holdings, Inc.	d0213cb3-ec8e-40cc-82c9-694032f0490f	2026-08-19	Warnings	Exact identifier application number: M022
CVS Health Sore Throat Fast Relief Oral Anesthetic	PHENOL	CVS Pharmacy,Inc.	4fb880db-2185-41ef-a5f9-8983a28d2c5b	2026-08-17	Warnings	Exact identifier application number: M022
CVS Sore Throat Cherry	PHENOL	CVS Pharmacy,Inc.	887c68e0-ff44-4bad-b360-56fb99ed9c45	2026-08-17	Warnings	Exact identifier application number: M022
CVS Sore Throat Menthol Flavor	PHENOL	CVS PHARMACY,INC.	665be058-b965-4b78-80b0-dd8524180932	2026-08-17	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Harris Teeter, LLC	7e5f175d-f0d6-4665-ac14-1873d6b99c80	2026-08-12	Warnings	Exact identifier application number: M022
Gingicaine Gel Variety Pak	GINGICAINE GEL VARIETY PAK	Gingi-Pak a Division of the Belport	62ed4ff3-18f6-5c67-e053-2991aa0a7792	2026-08-11	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent ReadyInCase	HYDROGEN PEROXIDE	P & L Development, LLC	b0866db5-3b0d-4478-9b3b-1f077d2f5393	2026-08-06	Warnings	Exact identifier application number: M022
Ollie Fresh Mint	SODIUM FLUORIDE, POTASSIUM NITRATE	Brio Product Group LLC.	ebeec44f-3c22-43f2-9256-6ece6025c105	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	5868c5a1-273f-f023-e063-6394a90ac9d8	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58690bb5-9604-26a4-e063-6394a90afdbe	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586918cf-7b13-5999-e063-6294a90a88a9	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586924a0-322d-5dc3-e063-6294a90a1556	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58692e90-de74-52d3-e063-6394a90a9702	2026-08-06	Warnings	Exact identifier application number: M022

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
238910	benzocaine 20 % Oral Gel	PSN	dbde8e7f-85d8-4083-b01a-3a7e410a7747	11
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	dbde8e7f-85d8-4083-b01a-3a7e410a7747	11
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	dbde8e7f-85d8-4083-b01a-3a7e410a7747	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-953-11	63868095311	1 TUBE in 1 CARTON (63868-953-11) / 11.76 g in 1 TUBE	1 tube	2013-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QC Maximum Strength Oral Analgesic 0.42oz 95362	Chain Drug Marketing Association Inc	2025-10-17	HUMAN OTC DRUG LABEL	11