Walgreens

Product NDC: 0363-5337
11-digit product format: 003635337
Labeler code: 0363
Product ID: 0363-5337_441e8e00-6237-a9d4-e063-6394a90a9929
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: PASTE, DENTIFRICE
Route: TOPICAL
Labeler: Walgreens
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-08-01
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0363-5337-19	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0363-5337-19	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0363-5337-19	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0363-5337-19	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-5337-19	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-5337-19	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-5337-19	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Walgreens
Brand name suffix: Maximum Strength
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
562785	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
2ef0eb2c-b614-44e2-b9b3-97b02c654977	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0363-5337-19	2025-06-10	C162847	48780-1	2cef2736-76aa-d83d-e063-dadaa90ab31f	5820337 Walgreens Max Str Oral Anesthetic Paste
0363-5337-19	2025-01-30	C162847	48780-1	2cef2736-76aa-d83d-e063-dadaa90ab31f	5820337 Walgreens Max Str Oral Anesthetic Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-5337-19	WalgreensMaximum Strength	12 g in 1 TUBE	PASTE, DENTIFRICE	12		14
0363-5337-19	WalgreensMaximum Strength	1 in 1 CARTON	PASTE, DENTIFRICE	1		14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]	1
PECTIN	INACTIVE INGREDIENT	89NA02M4RX	WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]	1
POLYETHYLENE GLYCOL 1000	INACTIVE INGREDIENT	U076Q6Q621	WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]	1
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-5337	WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]	10	Current NDC, Legacy NDC, 2 package rows	20230112_2ef0eb2c-b614-44e2-b9b3-97b02c654977.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 10 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Pro-Health Breath Purify and Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d71ed31f-cc33-2fc3-e053-2995a90ad39b	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Clinical	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	0a295ee0-55c2-4f21-8f0a-70efc0e51694	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d721e2cb-8f67-3d07-e053-2995a90ae65a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Advantage	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	ddcd56fe-25d6-8195-e053-2a95a90a575a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Bacteria Guard	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c2dc1f31-625d-a032-e053-2995a90a730d	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro Health Gum plus Bacteria Guard	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c598a4ab-5981-0068-e053-2a95a90af4fa	2026-01-08	Warnings	Exact identifier application number: M022
Oral B Gum Detoxify Special Care Rinse	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c2dcdde4-5542-1f87-e053-2995a90a261c	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Intense Fresh Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	62991165-ec81-48a8-e053-2991aa0a54f3	2026-01-08	Warnings	Exact identifier application number: M022
Crest Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	72f1a02f-1d02-7e83-e053-2a91aa0a7947	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Intense Clean Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	6287bc3e-8b05-45d3-e053-2991aa0aaa10	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Multi-Protection Refreshing Clean Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	8867d791-7e93-4f39-aaaf-bfbee8296fd9	2026-01-08	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Cream	BENZOCAINE	HEB	a71c5259-cbcf-7566-e053-2995a90a2cb6	2026-01-08	Warnings	Exact identifier application number: M022
Topco Associates LLC Maximum Strength	FLUORIDE	Topco Associates LLC	387d264c-90cc-5e67-e063-6394a90a713d	2026-01-08	Warnings	Exact identifier application number: M022
TopCare Sensitive Extra Whitening	POTASSIUM NITRATE, SODIUM FLUORIDE	TOPCO Assoc. LLC	835f41cf-e920-7df7-e053-2a91aa0a4479	2026-01-08	Warnings	Exact identifier application number: M022
Scope Icy Blast	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	164ed151-01d3-021a-e063-6294a90a0e51	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Advanced Enamel Care	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	1660e7d7-5b8d-8aba-e063-6294a90a50d8	2026-01-08	Warnings	Exact identifier application number: M022
Crest Deep Cleanse Germ Treatment	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	2d6b15d4-7827-ec2f-e063-6294a90a82c8	2026-01-08	Warnings	Exact identifier application number: M022
Crest Scope Original	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	21eed451-9368-146c-e063-6294a90af62b	2026-01-08	Warnings	Exact identifier application number: M022
3x Medicated Mouth Sore Gel	BENZOCAINE	HEB	a71c5259-cbd1-7566-e053-2995a90a2cb6	2026-01-08	Warnings	Exact identifier application number: M022
HEB Extra Whitening	FLUORIDE	HEB	b76c3591-6383-4661-b3db-7a56b11202f7	2026-01-08	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
562785	benzocaine 20 % Oral Paste	PSN	2ef0eb2c-b614-44e2-b9b3-97b02c654977	14
562785	benzocaine 0.2 MG/MG Oral Paste	SCD	2ef0eb2c-b614-44e2-b9b3-97b02c654977	14
562785	benzocaine 20 % Mucous Membrane Paste	SY	2ef0eb2c-b614-44e2-b9b3-97b02c654977	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-5337-19	00363533719	1 TUBE in 1 CARTON (0363-5337-19) / 12 g in 1 TUBE	1 tube	2013-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
5820337 Walgreens Max Str Oral Anesthetic Paste	Walgreens \| Lornamead Products	2025-11-21	HUMAN OTC DRUG LABEL	14