Home NDC 36800-512 TopCare Oral Pain Relief
Product NDC 36800-512
11-digit product format 368000512
Labeler code 36800
Product ID 36800-512_437fcc59-02bc-7d8c-e063-6394a90af1c0
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route TOPICAL
Labeler Topco Associates LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-05
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 · 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 36800-512 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 36800-512 36800-512-29 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 TopCare Oral Pain Relief
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 238910 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-512-29 TopCare Oral Pain ReliefMaximum Strength 14 g in 1 TUBE GEL 14 14 36800-512-29 TopCare Oral Pain ReliefMaximum Strength 1 in 1 CARTON GEL 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-512 TOPCARE ORAL PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) GEL [TOPCO ASSOCIATES LLC] 12 Current NDC, Legacy NDC, 2 package rows 20250121_835fb6ac-dbb7-5566-e053-2991aa0af5e2.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 15 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 36800-512-29 36800051229 1 TUBE in 1 CARTON (36800-512-29) / 14 g in 1 TUBE 1 tube 2019-03-05 0000-00-00 No No Current