HEB Mouth Sore Relief

Product NDC
37808-312
11-digit product format
378080312
Labeler code
37808
Product ID
37808-312_f202ed09-ce2d-6f27-e053-2a95a90ad894
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride, benzocaine, zinc chloride
Dosage form
GEL
Route
TOPICAL
Labeler
HEB
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-02-19
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE; ZINC CHLORIDE
Active strength
0 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
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-312-292025-01-30C16284748780-12cef2736-acaa-d83d-e063-dadaa90ab31fHEB Mouth Sore Relief Triple Med Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-312-29HEB Mouth Sore Relief1 in 1 CARTONGEL110
37808-312-29HEB Mouth Sore Relief11.9 g in 1 TUBEGEL11.910

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-312HEB MOUTH SORE RELIEF (BENZALKONIUM CHLORIDE, BENZOCAINE, ZINC CHLORIDE) GEL [HEB]10Legacy NDC, 2 package rows20230112_8246a419-f8b1-4d99-e053-2991aa0ac4ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1042836benzalkonium chloride 0.02 % / benzocaine 20 % / zinc chloride 0.1 % Oral GelPSN8246a419-f8b1-4d99-e053-2991aa0ac4ac10
1042836benzalkonium chloride 0.0002 MG/MG / benzocaine 0.2 MG/MG / zinc chloride 0.001 MG/MG Oral GelSCD8246a419-f8b1-4d99-e053-2991aa0ac4ac10
1042836benzalkonium chloride 0.02 % / benzocaine 20 % / zinc chloride 0.1 % Oral GelSY8246a419-f8b1-4d99-e053-2991aa0ac4ac10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-312-29378080312291 TUBE in 1 CARTON (37808-312-29) > 11.9 g in 1 TUBE1 tube2019-02-190000-00-00NoNoCurrent