FDA.reportPublic FDA data

Campho-Phenique

Product NDC
69536-108
11-digit product format
695360108
Labeler code
69536
Product ID
69536-108_284cb346-f76b-53af-e063-6394a90a2aa4
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR (SYNTHETIC) and PHENOL
Dosage form
GEL
Route
TOPICAL
Labeler
Foundation Consumer Healthcare LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-01
Substance
CAMPHOR (SYNTHETIC); PHENOL
Active strength
10.8; 4.7 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Campho-Phenique
Brand name suffix
Cold Sore Treatment
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, 339NCG44TV
Rxcui210347, 308939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-108-23Campho-PheniqueCold Sore Treatment1 in 1 CARTONGEL14
69536-108-23Campho-PheniqueCold Sore Treatment6.5 g in 1 TUBEGEL6.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69536-108-23GM - Gram69536-108b40c8512-2d68-44e7-ac9a-7b8c3944fec412018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-108CAMPHO-PHENIQUE COLD SORE TREATMENT (CAMPHOR (SYNTHETIC) AND PHENOL) GEL [FOUNDATION CONSUMER HEALTHCARE LLC]4Current NDC, Legacy NDC, 2 package rows20241204_106c0bb2-f2e2-4255-867d-d09ff6a5a2e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210347Campho-Phenique 10.8 % / 4.7 % Topical GelPSN106c0bb2-f2e2-4255-867d-d09ff6a5a2e64
308939camphor 10.8 % / phenol 4.7 % Topical GelPSN106c0bb2-f2e2-4255-867d-d09ff6a5a2e64
210347camphor 0.108 MG/MG / phenol 0.047 MG/MG Topical Gel [Campho-Phenique]SBD106c0bb2-f2e2-4255-867d-d09ff6a5a2e64
308939camphor 0.108 MG/MG / phenol 0.047 MG/MG Topical GelSCD106c0bb2-f2e2-4255-867d-d09ff6a5a2e64
210347Campho-Phenique (camphor 10.8 % / phenol 4.7 % ) Topical GelSY106c0bb2-f2e2-4255-867d-d09ff6a5a2e64
308939camphor 0.11 MG/MG / phenol 0.05 MG/MG Topical GelSY106c0bb2-f2e2-4255-867d-d09ff6a5a2e64
308939camphor 10.8 % / phenol 4.7 % Topical GelSY106c0bb2-f2e2-4255-867d-d09ff6a5a2e64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69536-108-23695360108231 TUBE in 1 CARTON (69536-108-23) / 6.5 g in 1 TUBE1 tube2017-08-010000-00-00NoNoCurrent