FDA.reportPublic FDA data

Maximum Strength Cold Sore Treatment

Product NDC
41250-411
11-digit product format
412500411
Labeler code
41250
Product ID
41250-411_ed54cd45-c7cf-4437-8773-95c4c3d37390
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Phenol, White Petrolatum
Dosage form
GEL
Route
TOPICAL
Labeler
Meijer Distribution Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-09-09
Substance
CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PHENOL; PETROLATUM
Active strength
30; 10; 15; 892 mg/g; mg/g; mg/g; mg/g
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
Maximum Strength Cold Sore Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)30 mg/g
MENTHOL, UNSPECIFIED FORM10 mg/g
PHENOL15 mg/g
PETROLATUM892 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
339NCG44TVInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2175793Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9220772c-b3b7-4855-e053-2a95a90a94f6Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41250-411-012021-02-17C16284748780-1ba0f9c33-3f6c-a910-e053-dadaa90a0b85Maximum Strength Cold Sore Treatment - Meijer
41250-411-012021-01-29C16284748780-1ba0f9c33-3f6c-a910-e053-dadaa90a0b85Maximum Strength Cold Sore Treatment - Meijer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-411-01Maximum Strength Cold Sore Treatment2 g in 1 TUBEGEL26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-411MAXIMUM STRENGTH COLD SORE TREATMENT (CAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUM) GEL [MEIJER DISTRIBUTION INC]6Current NDC, Legacy NDC, 1 package rows20241128_9220772c-b3b7-4855-e053-2a95a90a94f6.zip

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 19 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Caref5252b4f-5e14-509e-e053-2995a90a6db82025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f199947-bf25-914b-e063-6394a90a8a6f2025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f199947-bf28-914b-e063-6394a90a8a6f2025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f19a1a7-c234-8d26-e063-6394a90ad7e92025-09-18WarningsExact identifier
application number: M022
McKesson Orasol GelBENZOCAINE 20%McKesson Medical-Surgicalcc8724f4-c482-5e7d-e053-2a95a90a608f2025-09-09WarningsExact identifier
application number: M022
MGC Health Drops Sugar Free Lemon MintMENTHOLMedical Group Care LLC3d70bca7-e830-e693-e063-6294a90a73f92025-08-28WarningsExact identifier
application number: M022
Exchange Select Drops Sugar Free Lemon MintMENTHOLArmy & Air Force Exchange Service3d70450f-04ea-1885-e063-6294a90a05bd2025-08-28WarningsExact identifier
application number: M022
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa2bad-5b8b-8aac-e063-6394a90a9f492025-08-27WarningsExact identifier
application number: M022
R CosCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa767a-1344-5ed9-e063-6394a90a5fe62025-08-27WarningsExact identifier
application number: M022
Na Mi CalCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cfbcd1-eb13-933c-e063-6294a90a7e592025-08-27WarningsExact identifier
application number: M022
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cf8f80-c638-4d94-e063-6294a90a54002025-08-27WarningsExact identifier
application number: M022
Charm Tex FLUORIDESODIUM MONOFLUOROPHOSPHATEYangzhou Hongshengding Chemical Co.,Ltd.63a69664-8611-4d69-b871-8d1d5b553e5c2025-08-18WarningsExact identifier
application number: M022
QUALITY CHOICE SALINESODIUM CHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f51491d8-12ad-4b1b-a171-c621bfdcc3412025-08-12WarningsExact identifier
application number: M022
MGC Health Drops Sugar Free Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.b9227966-847c-40c3-87f2-8bea3954ec842025-08-12WarningsExact identifier
application number: M022
Exchange Select Drops Sugar Free Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.5f4b1960-43ac-4c74-9410-210c48bd8a1b2025-08-12WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC113cdb83-0fdd-40f2-8ee6-b771dca997132025-08-12WarningsExact identifier
application number: M022
CVS Pharmacy Maximum StrengthBENZOCAINECVS Pharmacy13bf31c1-78e3-459f-9249-b0b6e2c17a132025-08-12WarningsExact identifier
application number: M022
Rexall Maximum StrengthBENZOCAINERexall8f6e2780-cfb7-4bef-9b7d-13cb80d8923e2025-08-12WarningsExact identifier
application number: M022
Walgreens Maximum StrengthBENZOCAINEWalgreens8f24309d-d393-455a-a9a5-a55344adf36b2025-08-12WarningsExact identifier
application number: M022
Oral Anesthetic LiquidBENZOCAINEMeijer, Inc.0321c480-e150-421d-e063-6294a90ad6872025-08-12WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2175793camphor 3 % / menthol 1 % / petrolatum 89.2 % / phenol 1.5 % Topical GelPSN9220772c-b3b7-4855-e053-2a95a90a94f66
2175793camphor 0.03 MG/MG / menthol 0.01 MG/MG / petrolatum 0.892 MG/MG / phenol 0.015 MG/MG Topical GelSCD9220772c-b3b7-4855-e053-2a95a90a94f66
2175793camphor 3 % / menthol 1 % / petrolatum 89.2 % / phenol 1.5 % Topical GelSY9220772c-b3b7-4855-e053-2a95a90a94f66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-411-01412500411012 g in 1 TUBE (41250-411-01) 2 g2019-09-090000-00-00NoNoCurrent