FDA.reportPublic FDA data

Carmex Classic Lip Balm Medicated

Product NDC
10210-0022
11-digit product format
102100022
Labeler code
10210
Product ID
10210-0022_30cb63cc-47f3-ac7b-e063-6294a90abe38
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR (SYNTHETIC), PETROLATUM
Dosage form
SALVE
Route
TOPICAL
Labeler
Carma Laboratories, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-26
Substance
CAMPHOR (SYNTHETIC); WHITE PETROLATUM
Active strength
1.7; 45.3 g/100g; g/100g
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
Carmex Classic Lip Balm Medicated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)1.7 g/100g
WHITE PETROLATUM45.3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
B6E5W8RQJ4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2475168Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e57Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0022-1Carmex Classic Lip Balm Medicated1 in 1 BLISTER PACKSALVE15
10210-0022-1Carmex Classic Lip Balm Medicated7.5 g in 1 JARSALVE7.55
10210-0022-2Carmex Classic Lip Balm Medicated3 in 1 PACKAGESALVE35
10210-0022-2Carmex Classic Lip Balm Medicated7.5 g in 1 JARSALVE7.55
10210-0022-3Carmex Classic Lip Balm Medicated7.5 g in 1 JARSALVE7.55
10210-0022-4Carmex Classic Lip Balm Medicated10 g in 1 TUBESALVE105
10210-0022-4Carmex Classic Lip Balm Medicated1 in 1 BLISTER PACKSALVE15
10210-0022-5Carmex Classic Lip Balm Medicated10 g in 1 TUBESALVE105
10210-0022-5Carmex Classic Lip Balm Medicated3 in 1 PACKAGESALVE35
10210-0022-6Carmex Classic Lip Balm Medicated10 g in 1 TUBESALVE105
10210-0022-7Carmex Classic Lip Balm Medicated12 in 1 BOXSALVE125
10210-0022-7Carmex Classic Lip Balm Medicated10 g in 1 TUBESALVE105
10210-0022-8Carmex Classic Lip Balm Medicated10 g in 1 TUBESALVE105
10210-0022-8Carmex Classic Lip Balm Medicated2 in 1 BLISTER PACKSALVE25
10210-0022-6Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 1510 g in 1 TUBESALVE30 g1.7 g in 100g1
10210-0022-6Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 1510 g in 1 TUBESALVE70 g45.3 g in 100g1
10210-0022-6Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 1510 g in 1 TUBESALVE10 g45.3 g in 100g1
10210-0022-6Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 1510 g in 1 TUBESALVE20 g1.7 g in 100g1
10210-0022-6Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 1510 g in 1 TUBESALVE30 g45.3 g in 100g1
10210-0022-6Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPF10 g in 1 TUBESALVE30 g1.7 g in 100g1
10210-0022-6Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 1510 g in 1 TUBESALVE10 g45.3 g in 100g1
10210-0022-6Carmex Classic Lip Balm Medicated10 g in 1 TUBESALVE20 g1.7 g in 100g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0022CARMEX CLASSIC LIP BALM MEDICATED (CAMPHOR (SYNTHETIC), PETROLATUM) SALVE [CARMA LABORATORIES, INC.]5Current NDC, Legacy NDC, 14 package rows20250322_fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e57.zip
10210-0022CARMEX CLASSIC LIP BALM MEDICATED FREE CUPCAKE BATTER STICK SUNSCREEN SPF 15 (CAMPHOR (SYNTHETIC), PETROLATUM) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20231206_5378d653-702d-405c-a067-882554aaf93a.zip
10210-0022CARMEX CLASSIC LIP BALM MEDICATED FREE CUPCAKE BATTER STICK SUNSCREEN SPF 15 (CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20231206_0bc6812a-5c2a-7bb9-e063-6294a90a36e3.zip
10210-0022CARMEX CLASSIC LIP BALM MEDICATED FREE STRAWBERRY STICK SUNSCREEN SPF 15 (CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20231206_34fae56e-367d-4659-af2d-1c9ddaf1639c.zip
10210-0022CARMEX VARIETY PACK CLASSIC MEDICATED LIP BALM DAILY CARE LIP BALM SPF (CAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20250402_5f904369-5f21-4907-98de-df23bce30823.zip
10210-0022CARMEX VARIETY PACK CLASSIC MEDICATED LIP BALM LIP BALM SPF 15 (CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20250402_3a3af6e1-0281-462e-85e7-144cc5d46f32.zip
10210-0022CARMEX VARIETY PACK CLASSIC MEDICATED LIP BALM LIP BALM SPF 15 (CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20250402_3a36a241-37a9-445a-a6e0-97709a7457a8.zip
10210-0022CARMEX VARIETY PACK CLASSIC MEDICATED LIP BALM LIP BALM SPF 15 (CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20250402_c04059e9-8175-46c2-8582-f84ef193abd3.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 54 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate hydrocortisoneHYDROCORTISONEWal-Mart Stores Inc70f4636d-4137-498b-ab81-0330de883e532025-12-15WarningsExact identifier
application number: M017
SALONPAS-HOT CAPSICUMCAPSAICINHisamitsu Pharmaceutical Co., Inc.ef5373aa-9857-4d01-95af-2d7716e54ae42025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLCf70a442e-7ba7-4860-e053-6394a90ac2bd2025-12-15WarningsExact identifier
application number: M017
Burn Ease, 3.5gBURN EASE, 3.5GProStat First Aid LLC004aa18f-3a97-f454-e063-6394a90afcff2025-12-15WarningsExact identifier
application number: M017
PS-3866 Burn Ease, 0.9gPS-3866 BURN EASE, 0.9GProStat First Aid LLC004d00a5-9cff-29ff-e063-6294a90aeb8c2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLC0037a1a4-d747-2567-e063-6394a90a721c2025-12-15WarningsExact identifier
application number: M017
PS-3885 Burn Ease, 3.5gPS-3885 BURN EASE, 3.5GProStat First Aid LLC004c6deb-2844-a0d0-e063-6394a90ae5e42025-12-15WarningsExact identifier
application number: M017
2677 First Aid Burn Cream2677 FIRST AID BURN CREAMProStat First Aid LLCff5bb628-8ef7-4540-e053-6394a90a55ed2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71b98b4-22d0-0124-e053-6394a90ae4cf2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71eb4f5-2280-5867-e053-6394a90aac572025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8e6842-c889-d5d3-e063-6394a90af8802025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8c59fb-3622-2bb7-e063-6294a90adc6e2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEFront Line Safety0e34cb09-d8c6-f8c0-e063-6294a90a0be02025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f52021f-af8a-5b95-e063-6294a90a2c2a2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLC0e25c936-e40a-e23c-e063-6294a90ac0e42025-12-15WarningsExact identifier
application number: M017
Sting Relief WipesSTING RELIEF WIPESProStat First Aid LLC0e20252a-5ecb-2526-e063-6294a90a8cde2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMFront Line Safety0f4ce2c2-f306-d95f-e063-6394a90ae7b32025-12-15WarningsExact identifier
application number: M017
Magsoothium BodyMENTHOL, CAPSAICINUbu/Elements, Inc.f604d30c-b17c-ec01-e053-2a95a90aa3042025-12-15WarningsExact identifier
application number: M017
Salonpas pain relieving JETMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.dd1ea3bf-891a-402e-8f43-14302bc9c3e52025-12-15WarningsExact identifier
application number: M017
Herbal Tendon Bone ReliefCAMPHOR MINTGuchutang Biotechnology (Longyan) Co., Ltd.45cf4040-9751-d24b-e063-6294a90aff272025-12-13WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSNfb6eb93b-7dc0-4b6f-bfe1-1a7b47588e575
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCDfb6eb93b-7dc0-4b6f-bfe1-1a7b47588e575
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSYfb6eb93b-7dc0-4b6f-bfe1-1a7b47588e575
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSN3a3af6e1-0281-462e-85e7-144cc5d46f321
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSNc04059e9-8175-46c2-8582-f84ef193abd31
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSN5f904369-5f21-4907-98de-df23bce308231
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSN5378d653-702d-405c-a067-882554aaf93a1
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSNc7a7626c-cf82-4301-af79-c5e85367e7771
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSN3a36a241-37a9-445a-a6e0-97709a7457a81
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSN34fae56e-367d-4659-af2d-1c9ddaf1639c1
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSN0bc6812a-5c2a-7bb9-e063-6294a90a36e31
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCD3a36a241-37a9-445a-a6e0-97709a7457a81
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCD3a3af6e1-0281-462e-85e7-144cc5d46f321
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCD34fae56e-367d-4659-af2d-1c9ddaf1639c1
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCD0bc6812a-5c2a-7bb9-e063-6294a90a36e31
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCD5378d653-702d-405c-a067-882554aaf93a1
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCD5f904369-5f21-4907-98de-df23bce308231
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCDc04059e9-8175-46c2-8582-f84ef193abd31
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCDc7a7626c-cf82-4301-af79-c5e85367e7771
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSY5378d653-702d-405c-a067-882554aaf93a1
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSYc7a7626c-cf82-4301-af79-c5e85367e7771
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSYc04059e9-8175-46c2-8582-f84ef193abd31
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSY5f904369-5f21-4907-98de-df23bce308231
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSY3a3af6e1-0281-462e-85e7-144cc5d46f321
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSY3a36a241-37a9-445a-a6e0-97709a7457a81
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSY34fae56e-367d-4659-af2d-1c9ddaf1639c1
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSY0bc6812a-5c2a-7bb9-e063-6294a90a36e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10210-0022-1102100022011 JAR in 1 BLISTER PACK (10210-0022-1) / 7.5 g in 1 JAR1 jar2016-09-260000-00-00NoNoCurrent
10210-0022-2102100022023 JAR in 1 PACKAGE (10210-0022-2) / 7.5 g in 1 JAR3 jar2016-09-260000-00-00NoNoCurrent
10210-0022-3102100022037.5 g in 1 JAR (10210-0022-3) 7.5 g2016-09-260000-00-00NoNoCurrent
10210-0022-4102100022041 TUBE in 1 BLISTER PACK (10210-0022-4) / 10 g in 1 TUBE1 tube2016-09-260000-00-00NoNoCurrent
10210-0022-5102100022053 TUBE in 1 PACKAGE (10210-0022-5) / 10 g in 1 TUBE3 tube2016-09-260000-00-00NoNoCurrent
10210-0022-61021000220610 g in 1 TUBE (10210-0022-6) 10 g2016-09-260000-00-00NoNoCurrent
10210-0022-71021000220712 TUBE in 1 BOX (10210-0022-7) / 10 g in 1 TUBE12 tube2023-01-01NoNoCurrent
10210-0022-8102100022082 TUBE in 1 BLISTER PACK (10210-0022-8) / 10 g in 1 TUBE2 tube2025-04-01NoNoCurrent