FDA.reportPublic FDA data

DERMFREE MEDICATED LIP

Product NDC
85248-113
11-digit product format
852480113
Labeler code
85248
Product ID
85248-113_572bba48-50ed-7f20-e063-6394a90ab160
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor 2.0% MEDICATED LIP
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-08
Substance
CAMPHOR (SYNTHETIC)
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
DERMFREE MEDICATED LIP
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2675876Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4a4d62fb-8dfa-404a-e063-6294a90a385dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-113-01DERMFREE MEDICATED LIP10 g in 1 TUBEOINTMENT101

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 137 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn First AidBURN FIRST AIDDynarex Corporation826e08be-dffa-5a27-e053-2a91aa0a87012024-01-22WarningsExact identifier
application number: M017
Target Up and Up Pain Relief Menthol Topical Analgesic Roll-OnMENTHOLTARGET CORPORATION0f95fc55-8665-9e89-e063-6394a90a78912024-01-22WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain Relief Plus MentholLIDOCAINE, MENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.77978069-a1b4-473e-83c9-8320e00eea892024-01-19WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPSCAMPHOR, MENTHOLKOBAYASHI Healthcare International, Inc.ba26635d-95d3-4d88-93cc-1fd4fd29fd792024-01-18WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthe95ebdac-9789-41c2-97da-2307e45387942024-01-18WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATEUnifirst First Aid Corporationbd216f5d-f304-7d8d-e053-2a95a90aa9ce2024-01-17WarningsExact identifier
application number: M017
Green Guard Hydrocortisone 1%HYDROCORTISONEUnifirst First Aid Corporationbd348e2a-57b1-3f17-e053-2a95a90a8bdc2024-01-17WarningsExact identifier
application number: M017
Pain ReliefLIDOCAINE, MENTHOLHUMN Pharmaceuticals Inc6c96f94a-e724-eab3-e053-2991aa0aab882024-01-17WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain ReliefLIDOCAINENatural Essentials, Inc.52e82e70-53b7-4ecb-be39-fe10c94cc4442024-01-17WarningsExact identifier
application number: M017
CVS Health XL Lidocaine Pain ReliefLIDOCAINENATURAL ESSENTIALS, INC.ec16da91-8244-402b-b8d8-84896094ac2c2024-01-17WarningsExact identifier
application number: M017
Anti-itchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATETarget Corporationf444b0a6-2ed3-4236-8206-3421502906752024-01-17WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone Anti-itchHYDROCORTISONE 1%Target Corporation4ff39cb8-3a20-4fe7-9829-1e882a4846682024-01-17WarningsExact identifier
application number: M017
BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.eca272cb-ac8f-982b-e053-2995a90aa8b22024-01-15WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cfde0-c463-e9b5-e053-2a95a90a19242024-01-15WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cce4b-c70a-1b2d-e053-2995a90aa4aa2024-01-15WarningsExact identifier
application number: M017
Oral Pain Relief GelBENZOCAINE 20%Sled Distribution, LLCe7391302-831e-14dc-e053-2a95a90ac2362024-01-15WarningsExact identifier
application number: M017
FIRST SHIELDLIDOCAINE HCIEver Ready First Aide022bf8f-3dd8-de22-e053-2995a90a219b2024-01-15WarningsExact identifier
application number: M017
FlexigenMENTHOL 1.25%Derma Care Research Labs, LLCe9ae2682-59b4-e796-e053-2995a90af9212024-01-15WarningsExact identifier
application number: M017
Vita-P Oral and NasalMENTHOL 1%Beijing HKKY Medical Tech. Co., Ltd.537c3843-1c92-41c6-b724-52701bbddeab2024-01-13WarningsExact identifier
application number: M017
Caring mill Lidocaine Aloe Gel Burn and Pain ReliefLIDOCAINE HYDROCHLORIDEFSA Store Inc.0ec20c87-1681-dd23-e063-6394a90a291c2024-01-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2675876camphor 2 % Topical OintmentPSN4a4d62fb-8dfa-404a-e063-6294a90a385d1
2675876camphor 0.02 MG/MG Topical OintmentSCD4a4d62fb-8dfa-404a-e063-6294a90a385d1
2675876camphor 2 % Topical OintmentSY4a4d62fb-8dfa-404a-e063-6294a90a385d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-113-018524801130110 g in 1 TUBE (85248-113-01) 10 g2026-02-08NoNoCurrent