Cold Sore Fast-Acting Pain Relief

Product NDC
10157-4103
11-digit product format
101574103
Labeler code
10157
Product ID
10157-4103_a8c93771-4bc0-4fdc-b943-b5920bedb988
Type
HUMAN OTC DRUG
Nonproprietary name
GLYCERIN and LIDOCAINE
Dosage form
GEL
Route
TOPICAL
Labeler
Blistex Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-01
Substance
GLYCERIN; LIDOCAINE
Active strength
200; 40 mg/g; mg/g
Pharmacologic classes
Allergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Local Anesthesia [PE], Non-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
Cold Sore Fast-Acting Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN200 mg/g
LIDOCAINE40 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, 98PI200987
Rxcui2719723

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-4103-1Cold Sore Fast-Acting Pain Relief4.25 g in 1 TUBEGEL4.252
10157-4103-1Cold Sore Fast-Acting Pain Relief1 in 1 BLISTER PACKGEL12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719723glycerin 20 % / lidocaine 4 % Topical GelPSNc7511322-dd6c-441c-bf7d-ad4f0c14956a2
2719723glycerin 0.2 MG/MG / lidocaine 0.04 MG/MG Topical GelSCDc7511322-dd6c-441c-bf7d-ad4f0c14956a2
2719723glycerin 20 % / lidocaine 4 % Topical GelSYc7511322-dd6c-441c-bf7d-ad4f0c14956a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10157-4103-1101574103011 TUBE in 1 BLISTER PACK (10157-4103-1) / 4.25 g in 1 TUBE1 tube2025-07-01NoNoCurrent