FDA.reportPublic FDA data

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2719723Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c7511322-dd6c-441c-bf7d-ad4f0c14956aAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 53 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ResinolPETROLATUM AND RESORCINOLResiCal, Inc.03f57a4a-f94b-4ba6-b709-41cfb6e162612025-12-17WarningsExact identifier
application number: M017
HealthWise Maximum Pain ReliefLIDOCAINEVeridian Healthcareafc3c16d-0076-44b2-ae7e-5f36d4d8088e2025-12-17WarningsExact identifier
application number: M017
HealthWise Max Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcaref39a27da-6799-4fc6-97ca-101eac4a93602025-12-17WarningsExact identifier
application number: M017
HealthWise Original MentholMENTHOLVeridian Healthcaree4bfb6b0-545e-4fbc-8538-4f41a6be10252025-12-17WarningsExact identifier
application number: M017
Welly Polka First Aid KitHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEDongguan Shenglian Tins Products Co., Ltd.d7c4314c-c4c6-4adf-b384-3ac7a71083192025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain TherapyMENTHOLWise Consumer Products2410a199-f4a3-da6c-e063-6394a90aaace2025-12-17WarningsExact identifier
application number: M017
LidocaineLIDOCAINE, MENTHOLVive Health LLC462d3b24-643e-91da-e063-6394a90a0e1d2025-12-17WarningsExact identifier
application number: M017
Teevodar Pain RelievingMENTHOLSod-e Biotech Ltd205b0fef-4f00-db2e-e063-6294a90a93b82025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain ReliefMENTHOLWISE CONSUMER PRODUCTS CO.116045df-891b-f370-e063-6294a90abe422025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Intensive Foot TherapyMENTHOLWise Consumer Products23e56c6b-0f2b-721f-e063-6394a90a1ed02025-12-17WarningsExact identifier
application number: M017
Tiger Balm Ultra StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f0561804-e0f7-495d-9768-9b86a208c51e2025-12-17WarningsExact identifier
application number: M017
Kwan LoongMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.54bcb26e-786a-403e-9330-11ae9e3c013a2025-12-17WarningsExact identifier
application number: M017
Magsoothium Body Cooling FormulaMENTHOLUbu/Elements, Inc.f7fb6ac9-a920-a440-e053-6394a90aaa352025-12-16WarningsExact identifier
application number: M017
Magsoothium CBD Body LavenderMENTHOLUbu/Elements, Inc.f9b87fbe-b889-67a1-e053-6394a90acbcd2025-12-16WarningsExact identifier
application number: M017
Aquaphor Itch ReliefHYDROCORTISONEBeiersdorf Incb1d0333f-ba60-35d8-e053-2995a90af9322025-12-16WarningsExact identifier
application number: M017
Magsoothium CBD BodyMENTHOLUbu/Elements, Inc.00b2ef34-42d7-523c-e063-6294a90a753d2025-12-16WarningsExact identifier
application number: M017
GENTLECARE HAND AND SKIN SANITIZERBENZALKONIUM CHLORIDEPARAGON SOLUTIONS US, INC.16650277-fa62-485e-9a82-7763d2b501682025-12-16WarningsExact identifier
application number: M017
Welly First Aid Kit RefillHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEDongguan Shenglian Tins Products Co., Ltd.4bc93855-4009-4b49-9fb4-e5864054153d2025-12-16WarningsExact identifier
application number: M017
LidocainePain pain reliving gel-patchPAIN RELIVING GEL-PATCHShenzhen Yuetai Electronic Commerce Co., Ltd461ebbdd-0f26-a333-e063-6394a90a7a3e2025-12-16WarningsExact identifier
application number: M017
ZestamaCAPSAICINV2 Pharma LLCc9b46759-b8df-4ff4-815e-8e032c2635c02025-12-15WarningsExact identifier
application number: M017

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