FDA.reportPublic FDA data

TANAC Oral Pain Reliever

Product NDC
69626-0049
11-digit product format
696260049
Labeler code
69626
Product ID
69626-0049_26f71ff3-08b2-6177-e063-6394a90ace74
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
ORAL
Labeler
Leosons Overseas Corp
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-01
Substance
BENZOCAINE
Active strength
10 g/100mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
TANAC Oral Pain Reliever
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui583152, 1053339

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69626-0049-42024-11-20C16284748780-10191ceaa-6169-198a-e063-dbdaa90aec3eTANAC Oral Pain Reliever
69626-0049-42023-07-28C16284748780-10191ceaa-6169-198a-e063-dbdaa90aec3eTANAC Oral Pain Reliever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69626-0049-4TANAC Oral Pain Reliever13.3 mL in 1 BOTTLELIQUID13.34
69626-0049-4TANAC Oral Pain Reliever1 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69626-0049TANAC ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [LEOSONS OVERSEAS CORP]4Current NDC, Legacy NDC, 2 package rows20241122_81cc61fa-31a7-2214-e053-2a91aa0ae46a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
583152benzocaine 10 % Mucous Membrane Topical SolutionPSN81cc61fa-31a7-2214-e053-2a91aa0ae46a4
1053339Tanac Liquid 10 % Mucous Membrane Topical SolutionPSN81cc61fa-31a7-2214-e053-2a91aa0ae46a4
1053339benzocaine 100 MG/ML Mucous Membrane Topical Solution [Tanac Liquid]SBD81cc61fa-31a7-2214-e053-2a91aa0ae46a4
583152benzocaine 100 MG/ML Mucous Membrane Topical SolutionSCD81cc61fa-31a7-2214-e053-2a91aa0ae46a4
583152benzocaine 10 % Mucous Membrane Topical SolutionSY81cc61fa-31a7-2214-e053-2a91aa0ae46a4
1053339Tanac Liquid 10 % Mucous Membrane Topical SolutionSY81cc61fa-31a7-2214-e053-2a91aa0ae46a4
1053339Tanac Liquid 100 MG/ML Mucous Membrane Topical SolutionSY81cc61fa-31a7-2214-e053-2a91aa0ae46a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69626-0049-4696260049041 BOTTLE in 1 CARTON (69626-0049-4) / 13.3 mL in 1 BOTTLE1 bottle2015-01-010000-00-00NoNoCurrent