Home NDC 0363-0607 4x Medicated Toothache and Gum Cream
Product NDC 0363-0607
11-digit product format 003630607
Labeler code 0363
Product ID 0363-0607_43956f7c-4305-e136-e063-6394a90a61d0
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form CREAM
Route ORAL
Labeler Walgreens
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-02
Substance BENZOCAINE; BENZALKONIUM CHLORIDE; ZINC CHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength 20; .13; .15; .26 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0363-0607 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0363-0607 0363-0607-79 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0363-0607 0363-0607-19 U Excluded because listing certification expired excluded / ndc_excluded.zip 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 4x Medicated Toothache and Gum Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 20 g/100g BENZALKONIUM CHLORIDE .13 g/100g ZINC CHLORIDE .15 g/100g MENTHOL, UNSPECIFIED FORM .26 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2370903 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-0607-19 4x Medicated Toothache and Gum Cream 1 in 1 CARTON CREAM 1 10 0363-0607-19 4x Medicated Toothache and Gum Cream 14 g in 1 TUBE CREAM 14 10 0363-0607-79 4x Medicated Toothache and Gum Cream 1 in 1 CARTON CREAM 1 10 0363-0607-79 4x Medicated Toothache and Gum Cream 9.4 g in 1 TUBE CREAM 9.4 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0607 4X MEDICATED TOOTHACHE AND GUM CREAM (BENZOCAINE) CREAM [WALGREENS] 8 Current NDC, Legacy NDC, 4 package rows 20250123_a71c2092-4ece-b82e-e053-2995a90ac933.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 97 of 151 · 3,010 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-0607-19 00363060719 1 TUBE in 1 CARTON (0363-0607-19) / 14 g in 1 TUBE 1 tube 2024-02-16 No No Current 0363-0607-79 00363060779 1 TUBE in 1 CARTON (0363-0607-79) / 9.4 g in 1 TUBE 1 tube 2020-06-02 0000-00-00 No No Current