Home NDC 69536-108 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 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 Cold Sore Treatment
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAMPHOR (SYNTHETIC) 10.8 g/100g PHENOL 4.7 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5TJD82A1ET Internal UNII lookup 339NCG44TV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 210347 Internal RxNorm lookup 308939 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69536-108-23 Campho-PheniqueCold Sore Treatment 1 in 1 CARTON GEL 1 4 69536-108-23 Campho-PheniqueCold Sore Treatment 6.5 g in 1 TUBE GEL 6.5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69536-108 CAMPHO-PHENIQUE COLD SORE TREATMENT (CAMPHOR (SYNTHETIC) AND PHENOL) GEL [FOUNDATION CONSUMER HEALTHCARE LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241204_106c0bb2-f2e2-4255-867d-d09ff6a5a2e6.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 80 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ELAIMEI Numbing Cream LIDOCAINE 4% Shenzhen Shandian Jingling Technology Co., Ltd. 37ac13b2-ca55-0e28-e063-6294a90a000e 2025-08-19 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY FSA Store Inc. 3cd18f96-34f7-3f2c-e063-6294a90a3b7e 2025-08-19 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE SPRAY FSA Store Inc. 3ce24b87-55ac-0bbd-e063-6294a90ab582 2025-08-19 Warnings Exact identifier application number: M017 Fast Freeze Pain Relieving MENTHOL, UNSPECIFIED FORM NATURAL ESSENTIALS, INC. 15a26af1-ca5a-40fc-a411-6c0e8ae18fbb 2025-08-18 Warnings Exact identifier application number: M017 Orythia Maximum Strength Lidocaine Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 6d6b59f9-f614-4e3c-b07b-32b4591d39f2 2025-08-18 Warnings Exact identifier application number: M017 Ocean Potion Suncare Ice Plus Pain Relieving Soothing LIDOCAINE GNL BRANDS INTERNATIONAL, LLC 3c69654c-cba6-dfef-e063-6394a90ad479 2025-08-15 Warnings Exact identifier application number: M017 Earth Mama Medicated Herbal Lip Balm MENTHOL Eleeo Brands LLC 3c6c16bb-1f4b-b851-e063-6294a90a7404 2025-08-15 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Cintas First Aid & Safety 96f17095-31f3-4b8a-ab22-0caaefaa7476 2025-08-15 Warnings Exact identifier application number: M017 MedPride Cold Ice Analgesic Gel MENTHOL SHIELD LINE LLC 860a2c86-b240-4e0e-e053-2a91aa0a333a 2025-08-15 Warnings Exact identifier application number: M017 MedPride Medicated Body Powder Powder MENTHOL, ZINC OXIDE Shield Line LLC cdb2fa5b-cf04-c876-e053-2a95a90a187c 2025-08-15 Warnings Exact identifier application number: M017 Burn LIDOCAINE HART Health c5ff392a-e788-43e0-91ea-5e0f8420586c 2025-08-15 Warnings Exact identifier application number: M017 Stopain Clinical MENTHOL Troy Manufacturing, Inc. 40df30ba-41ba-42b7-93fe-4183b57bdb00 2025-08-14 Warnings Exact identifier application number: M017 Signature Care Aloe Vera Gel with Lidocaine LIDOCAINE Safeway, Inc. d5069622-97b1-ba12-e053-2a95a90a7268 2025-08-14 Warnings Exact identifier application number: M017 METHYL SALICYLATE 25% METHYL SALICYLATE Oncora Pharma, LLC 3c4bc55d-6582-3b5e-e063-6394a90a994c 2025-08-13 Warnings Exact identifier application number: M017 Lidocaine 3% LIDOCAINE HCL 3% PureTek Corporation 3bc94d52-fe52-9fd6-e063-6294a90a4340 2025-08-12 Warnings Exact identifier application number: M017 Fast Freeze MENTHOL Natural Essentials Inc. d8c42c8d-6ce0-43bf-b165-41979f3d8f79 2025-08-12 Warnings Exact identifier application number: M017 Careland X-large Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. a6867506-4a46-47b1-b5b6-bfedb59dfde6 2025-08-11 Warnings Exact identifier application number: M017 Dermedial Anti-Ouch MENTHOL Saje Natural Business Inc. 3c194b8f-cfa5-11e3-e063-6394a90a92de 2025-08-11 Warnings Exact identifier application number: M017 Thera Plus Extra Strength Muscle Rub Topical Analgesic MENTHOL FOURSTAR GROUP USA, INC. 8a3b6adf-afbb-4d77-a19b-a6514ebd3b50 2025-08-11 Warnings Exact identifier application number: M017 EARTHS CARE ARTHRITIS CAPSAICIN DLC Laboratories, Inc. 9460674b-057e-40b9-a0f9-ca3d92068d4f 2025-08-11 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69536-108-23 69536010823 1 TUBE in 1 CARTON (69536-108-23) / 6.5 g in 1 TUBE 1 tube 2017-08-01 0000-00-00 No No Current