Home NDC 37808-691 3x Medicated Mouth Sore Gel
Product NDC 37808-691
11-digit product format 378080691
Labeler code 37808
Product ID 37808-691_47e54275-5f0e-b73b-e063-6294a90a7a8c
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route ORAL
Labeler HEB
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-02
Substance MENTHOL, UNSPECIFIED FORM; BENZOCAINE; ZINC CHLORIDE
Active strength .1; 20; .15 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 2027-12-31
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 · 2 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 37808-691 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 37808-691 37808-691-19 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 3x Medicated Mouth Sore Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM .1 g/100g BENZOCAINE 20 g/100g ZINC CHLORIDE .15 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup U3RSY48JW5 Internal UNII lookup 86Q357L16B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2266762 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 37808-691-19 3x Medicated Mouth Sore Gel 1 in 1 CARTON GEL 1 6 37808-691-19 3x Medicated Mouth Sore Gel 9.4 g in 1 TUBE GEL 9.4 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-691 3X MEDICATED MOUTH SORE GEL (BENZOCAINE) GEL [HEB] 3 Current NDC, Legacy NDC, 2 package rows 20250121_a71c5259-cbd1-7566-e053-2995a90a2cb6.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 9 of 40 · 786 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 37808-691-19 37808069119 1 TUBE in 1 CARTON (37808-691-19) / 9.4 g in 1 TUBE 1 tube 2020-06-02 0000-00-00 No No Current