Campho-Phenique

Product NDC
69536-110
11-digit product format
695360110
Labeler code
69536
Product ID
69536-110_284f74b6-532e-3ad8-e063-6394a90aae6b
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR (SYNTHETIC) and PHENOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Foundation Consumer Healthcare LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-06-01
Substance
CAMPHOR (SYNTHETIC); PHENOL
Active strength
10.8; 4.7 mg/100mL; mg/100mL
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
Campho-Phenique
Brand name suffix
Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)10.8 mg/100mL
PHENOL4.7 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
210346Internal RxNorm lookup
308940Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
82edaef0-0709-4ae1-a664-c9c5adb91ee1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-110-75Campho-PheniqueAntiseptic22 mL in 1 BOTTLELIQUID224
69536-110-75Campho-PheniqueAntiseptic1 in 1 CARTONLIQUID14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69536-110-75ML - Milliliter69536-1105045bc44-6efd-4074-a413-7e8d9658ecab12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-110CAMPHO-PHENIQUE ANTISEPTIC (CAMPHOR (SYNTHETIC) AND PHENOL) LIQUID [FOUNDATION CONSUMER HEALTHCARE LLC]4Current NDC, Legacy NDC, 2 package rows20241204_82edaef0-0709-4ae1-a664-c9c5adb91ee1.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 133 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.1dc21c95-b419-4175-85f8-040b73060d372024-03-20WarningsExact identifier
application number: M017
Pain Relief Roll-On MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.d94ae654-ce25-4bff-b9bd-24a0e0e8568a2024-03-20WarningsExact identifier
application number: M017
Pain Relief MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.f8bff018-fb4f-47b4-b8f8-4a496aede3462024-03-20WarningsExact identifier
application number: M017
Rugby Arthritis Pain Relieving Topical AnalgesicCAPSAICINRugby Laboratories8f1bc075-97ac-4154-8768-0d878104c3ba2024-03-14WarningsExact identifier
application number: M017
Rugby Ice Blue External AnalgesicMENTHOL, UNSPECIFIED FORMRugby Laboratories2b65cb6a-4364-4770-b7b9-5c4637edd01a2024-03-14WarningsExact identifier
application number: M017
Leader Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERfd06d17f-4dff-42a9-a84f-904809ceb9812024-03-13WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHOREROS GLOBALb3495c95-ba4b-9459-e053-2a95a90a710f2024-03-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONETRIFECTA PHARMACEUTICALS USA LLC1369e70f-7a61-7078-e063-6394a90a9a882024-03-11WarningsExact identifier
application number: M017
Pain Reliever CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.130665d6-3de8-cb91-e063-6294a90a20832024-03-06WarningsExact identifier
application number: M017
Dermachange Aid Anti-ItchDIPHENHYDRAMINE HCLPrivate Label Beauty and Wellness12ed906c-d028-0ff7-e063-6394a90aaa522024-03-05WarningsExact identifier
application number: M017
Dermachange Cold TherapyMENTHOLPrivate Label Beauty and Wellness12ef7dd8-3da3-9c87-e063-6394a90ac9242024-03-05WarningsExact identifier
application number: M017
Dermachange Arthritis ReliefTROLAMIN SALICYLATEPrivate Beauty Label and Wellness12dbfa50-1b97-f988-e063-6394a90a662c2024-03-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.b0f4010c-995f-40e1-aa40-92760e697a612024-03-02WarningsExact identifier
application number: M017
Icy Hot Advanced ReliefCAMPHOR AND MENTHOLChattem, Inc.9979ff36-415b-44e4-bb10-6bf682cd00f92024-03-01WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLC5051b650-18a4-481e-a8d7-d41d4ae51efd2024-02-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONETRIFECTA PHARMACEUTICALS USA LLC2999fecb-cb15-4023-ade4-ab5822b094d52024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8MENTHOLAmish Origins Management, LLCaaad56d5-6737-4edc-af0e-8e207695c0ec2024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLCb120404f-5a07-4182-bb50-d943418622da2024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLC437491ca-60ff-4508-b408-f97e7152f6382024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLCffe15aed-ea90-4db8-aace-d691a81c05ae2024-02-29WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210346Campho-Phenique 10.8 % / 4.7 % Topical SolutionPSN82edaef0-0709-4ae1-a664-c9c5adb91ee14
308940camphor 10.8 % / phenol 4.7 % Topical SolutionPSN82edaef0-0709-4ae1-a664-c9c5adb91ee14
210346camphor 108 MG/ML / phenol 47 MG/ML Topical Solution [Campho-Phenique]SBD82edaef0-0709-4ae1-a664-c9c5adb91ee14
308940camphor 108 MG/ML / phenol 47 MG/ML Topical SolutionSCD82edaef0-0709-4ae1-a664-c9c5adb91ee14
210346Campho-Phenique (camphor 10.8 % / phenol 4.7 % ) Topical SolutionSY82edaef0-0709-4ae1-a664-c9c5adb91ee14
210346Campho-Phenique (camphor 108 MG/ML / phenol 47 MG/ML) Topical SolutionSY82edaef0-0709-4ae1-a664-c9c5adb91ee14
308940camphor 10.8 % / phenol 4.7 % Topical SolutionSY82edaef0-0709-4ae1-a664-c9c5adb91ee14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69536-110-75695360110751 BOTTLE in 1 CARTON (69536-110-75) / 22 mL in 1 BOTTLE1 bottle2021-11-150000-00-00NoNoCurrent