ORAL PAIN RELIEF

Product NDC
43473-100
11-digit product format
434730100
Labeler code
43473
Product ID
43473-100_4cc7d90b-e806-8b9e-e063-6394a90a886e
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
ORAL
Labeler
Nantong Health & Beyond Hygienic Products Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ORAL PAIN RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43473-100-04ORAL PAIN RELIEF11.9 g in 1 TUBEGEL11.91
43473-100-04ORAL PAIN RELIEF1 in 1 BOXGEL11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNa5f0be98-d47e-4307-8044-304a64db774b1
238910benzocaine 0.2 MG/MG Oral GelSCDa5f0be98-d47e-4307-8044-304a64db774b1
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYa5f0be98-d47e-4307-8044-304a64db774b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43473-100-04434730100041 TUBE in 1 BOX (43473-100-04) / 11.9 g in 1 TUBE1 tube2026-03-11NoNoHistorical