Home NDC 37808-313-49 HEB Severe Toothache and Gum Relief
Product NDC 37808-313
Requested package NDC 37808-313-49
11-digit product format 378080313
Labeler code 37808
Product ID 37808-313_f2030113-fc98-6bee-e053-2995a90a10f6
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium chloride, Benzocaine, Menthol
Dosage form CREAM
Route TOPICAL
Labeler HEB
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2019-02-20
Marketing end 0000-00-00
Substance BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL
Active strength 0 g/100g; g/100g; 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 2024-12-31
Current FDA listing Historical FDA.report record 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 37808-313-49 HEB Severe Toothache and Gum ReliefTriple Medicated 1 in 1 CARTON CREAM 1 10 37808-313-49 HEB Severe Toothache and Gum ReliefTriple Medicated 9.3 g in 1 TUBE CREAM 9.3 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-313 HEB SEVERE TOOTHACHE AND GUM RELIEF TRIPLE MEDICATED (BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL) CREAM [HEB] 10 Legacy NDC, 2 package rows 20230112_82586cb7-797c-e239-e053-2a91aa0af79c.zip
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 37808-313-49 37808031349 1 TUBE in 1 CARTON (37808-313-49) > 9.3 g in 1 TUBE 1 tube 2019-02-20 0000-00-00 No No Current