HEB Severe Toothache and Gum Relief

Product NDC
37808-313
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-313-492025-01-30C16284748780-12cef2736-6fbd-d83d-e063-dadaa90ab31fHEB Severe Toothache & Gum Relief Triple Medicated Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-313-49HEB Severe Toothache and Gum ReliefTriple Medicated1 in 1 CARTONCREAM110
37808-313-49HEB Severe Toothache and Gum ReliefTriple Medicated9.3 g in 1 TUBECREAM9.310

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-313HEB SEVERE TOOTHACHE AND GUM RELIEF TRIPLE MEDICATED (BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL) CREAM [HEB]10Legacy NDC, 2 package rows20230112_82586cb7-797c-e239-e053-2a91aa0af79c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483194benzalkonium chloride 0.1 % / benzocaine 20 % / menthol 0.25 % Topical CreamPSN82586cb7-797c-e239-e053-2a91aa0af79c10
1483194benzalkonium chloride 1 MG/ML / benzocaine 200 MG/ML / menthol 2.5 MG/ML Topical CreamSCD82586cb7-797c-e239-e053-2a91aa0af79c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-313-49378080313491 TUBE in 1 CARTON (37808-313-49) > 9.3 g in 1 TUBE1 tube2019-02-200000-00-00NoNoCurrent