FDA.reportPublic FDA data

Campho-Phenique

Product NDC
69536-109
11-digit product format
695360109
Labeler code
69536
Product ID
69536-109_47f72480-dce3-904c-e063-6294a90a67d6
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor (synthetic) and Phenol
Dosage form
GEL
Route
TOPICAL
Labeler
Foundation Consumer Healthcare
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-15
Marketing end
2027-04-30
Substance
CAMPHOR (SYNTHETIC); PHENOL
Active strength
10.8; 4.7 g/100g; g/100g
NDC exclude flag
No
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)10.8 g/100g
PHENOL4.7 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
339NCG44TVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
210347Internal RxNorm lookup
308939Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46b84e0b-78a9-4cde-9f90-e165b5419162Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-109-50Campho-PheniqueAntiseptic14 g in 1 TUBEGEL145
69536-109-50Campho-PheniqueAntiseptic1 in 1 CARTONGEL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69536-109-50GM - Gram69536-1099f98ac0b-df65-4c7b-b67e-d3e105c70b2612018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-109CAMPHO-PHENIQUE ANTISEPTIC (CAMPHOR (SYNTHETIC) AND PHENOL) GEL [FOUNDATION CONSUMER HEALTHCARE]4Current NDC, Legacy NDC, 2 package rows20241204_46b84e0b-78a9-4cde-9f90-e165b5419162.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 70 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Medicated HeatCAPSICUM EXTRACTCVS Pharmacy81cd1019-93a6-311b-e053-2991aa0a79972025-10-28WarningsExact identifier
application number: M017
Foster and ThriveLIDOCAINESTRATEGIC SOURCING SERVICES, LLCf950b072-d978-b629-e053-6394a90abfaf2025-10-28WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
application number: M017
PRMENTHOLAmphp, Inc6f5b9e08-c445-4fac-e053-2a91aa0aa7372025-10-27WarningsExact identifier
application number: M017
LidocaineBURN RELIEFFoodhold USAb25dc0df-02d0-41ac-b36c-2c04baa77ef22025-10-27WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREEFSA Store Inc.fb3548c8-f202-dc50-e053-6394a90a5b302025-10-27WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CONTINUOUS SPRAYPremier Brands of America, Inc.d344f68b-9b62-3029-e053-2995a90a16652025-10-27WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATE 1%Unifirst First Aid Corporationf2b46d69-1c21-5ae9-e053-2a95a90a60a92025-10-24WarningsExact identifier
application number: M017
Extra StrengthMENTHOL AND METHYL SALICYLATESaje Natural Business Inc.87d872b3-3231-d0f2-e053-2995a90a9d982025-10-24WarningsExact identifier
application number: M017
Coralite Odor Free Pain ReliefLIDOCAINEUnited Exchange Corporation7966d9f2-22f9-a900-e053-2991aa0aba552025-10-24WarningsExact identifier
application number: M017
Signature Care Cold and HotMENTHOL, AND METHYL SALICYLATESafeway Inc.ab201023-e3dc-52ec-e053-2995a90a1f182025-10-24WarningsExact identifier
application number: M017
HealthWise Medicated Cold Hot 5% PatchMENTHOLVeridian Healthcare15aef56f-cd25-05ac-e063-6394a90a07bb2025-10-23WarningsExact identifier
application number: M017
AlivioLIDOCAINEAmerise Pharmaceuticals LLCeb3a98f1-c875-4f08-8b4b-44e22626b6092025-10-23WarningsExact identifier
application number: M017
Pain Relieveing Gel-PatchLIDOCAINEBullet point LLC41d507c4-ad37-2686-e063-6394a90aae5b2025-10-23WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP98fa9a34-0e1e-0997-e053-2a95a90ac77d2025-10-23WarningsExact identifier
application number: M017
Coralite Pain Relief HotMENTHOL AND CAPSAICINUnited Exchange Corporation78eb133d-01bb-6466-e053-2991aa0accc02025-10-23WarningsExact identifier
application number: M017
AmericaineBENZOCAINEInsight Pharmaceuticals LLC4fd14452-0285-40c4-b835-36935c2056b22025-10-23WarningsExact identifier
application number: M017
zourunan PAIN RELIEFPAIN RELIEFGuchutang Biotechnology (Longyan) Co., Ltd41bc1c0c-63d5-0d41-e063-6394a90a341b2025-10-22WarningsExact identifier
application number: M017
zourunan PAIN RELIEFPAIN RELIEFGuchutang Biotechnology (Longyan) Co., Ltd41bd0769-6ba0-d0d5-e063-6294a90af7c92025-10-22WarningsExact identifier
application number: M017
Coralite Extra Strength Pain Relief Sleeve KneeMENTHOLUnited Exchange Corp.aa5873bd-af64-41cc-8f16-7714c56bca962025-10-22WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210347Campho-Phenique 10.8 % / 4.7 % Topical GelPSN46b84e0b-78a9-4cde-9f90-e165b54191625
308939camphor 10.8 % / phenol 4.7 % Topical GelPSN46b84e0b-78a9-4cde-9f90-e165b54191625
210347camphor 0.108 MG/MG / phenol 0.047 MG/MG Topical Gel [Campho-Phenique]SBD46b84e0b-78a9-4cde-9f90-e165b54191625
308939camphor 0.108 MG/MG / phenol 0.047 MG/MG Topical GelSCD46b84e0b-78a9-4cde-9f90-e165b54191625
210347Campho-Phenique (camphor 10.8 % / phenol 4.7 % ) Topical GelSY46b84e0b-78a9-4cde-9f90-e165b54191625
308939camphor 0.11 MG/MG / phenol 0.05 MG/MG Topical GelSY46b84e0b-78a9-4cde-9f90-e165b54191625
308939camphor 10.8 % / phenol 4.7 % Topical GelSY46b84e0b-78a9-4cde-9f90-e165b54191625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69536-109-50695360109501 TUBE in 1 CARTON (69536-109-50) / 14 g in 1 TUBE1 tube2021-11-152027-04-30NoNoCurrent