FDA.reportPublic FDA data

Germa Manteca Ubre Plus (RED)

Product NDC
73635-5804
11-digit product format
736355804
Labeler code
73635
Product ID
73635-5804_5d6d942e-87c3-a662-e063-6294a90ac43a
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate 10%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Germa Products, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-29
Substance
METHYL SALICYLATE
Active strength
100 mg/mL
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
Germa Manteca Ubre Plus (RED)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE100 mg/mL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-05-09Manteca Ubre Plus (RED)
2023-05-09Manteca Ubre Plus (RED)
2023-05-09Manteca Ubre Plus (RED)
2023-01-30Manteca Ubre Plus (RED)
2023-01-30Manteca Ubre Plus (RED)
2023-01-30Manteca Ubre Plus (RED)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73635-5804-3Germa Manteca Ubre Plus (RED)85.5 mL in 1 JAROINTMENT85.55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73635-5804GERMA MANTECA UBRE PLUS (RED) (METHYL SALICYLATE 10%) OINTMENT [GERMA PRODUCTS, LLC]4Current NDC, Legacy NDC, 1 package rows20241017_bf9060df-6886-6381-e053-2995a90aa0df.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 5 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RELIBONEOintmentTOPICAL ANALGESICOINTMENTGuangdong Jiaoyu Biotechnology Co., Ltd58ddaaf6-18ec-8c5b-e063-6294a90a28282026-08-12WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58de3a29-2bec-6e44-e063-6394a90a9c1a2026-08-12WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsExact identifier
application number: M017
Muscle Rub CreamMUSCLE RUBALLIED TRADE LINK LLC11d33e60-8c64-4316-a29a-d17e3e6e4a282026-08-11WarningsExact identifier
application number: M017
Gee GasonMALE GENITAL DESENSITIZERMon Gars Boutique Inc58c75e5c-b801-017f-e063-6394a90a1c752026-08-11WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58c84330-15bf-c397-e063-6394a90aba052026-08-11WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy0e988da1-1904-431d-a152-bdb2aacc8e162026-08-11WarningsExact identifier
application number: M017
Medicated BODYMENTHOLCVS Pharmacy, Inc.a0f61498-69c8-4ce0-bbd7-3a807f192d362026-08-11WarningsExact identifier
application number: M017
Muscle MoveMENTHOLSaje Natural Wellness Inc.526d3305-4cf8-2fc5-e063-6394a90ad53b2026-08-10WarningsExact identifier
application number: M017
Relieve and Relax Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLMAC Innovations, LLCc0528c36-d322-8110-e053-2995a90add6c2026-08-08WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOLCVS Pharmacy4aa629f5-8b8f-cc67-e063-6394a90a019f2026-08-07WarningsExact identifier
application number: M017
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsExact identifier
application number: M017
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy46921bea-fcbe-94d6-e063-6394a90a726b2026-08-07WarningsExact identifier
application number: M017
CVS Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Pharmacy524605f9-8b04-b600-e063-6394a90a4a022026-08-07WarningsExact identifier
application number: M017
LidonexLIDOCAINE HCL, MENTHOLAldama Pharmaceuticals, Inc365cf19c-70e0-c4e9-e063-6294a90ac4282026-08-07WarningsExact identifier
application number: M017
Blaster Pain Relief StickMENTHOL, METHYL SALICYLATE, CAMPHORKalahari Rose, LLC587d660a-5f80-de5a-e063-6394a90aa2872026-08-07WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECardinal Health, 110 dba Leader3ed7b8a1-012f-459d-878c-813b93d4673c2026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLThe Kroger Co.6fb0acc8-8dab-452c-b09e-de97306e1c322026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2536330methyl salicylate 10 % Topical OintmentPSNbf9060df-6886-6381-e053-2995a90aa0df5
2536330methyl salicylate 0.1 MG/MG Topical OintmentSCDbf9060df-6886-6381-e053-2995a90aa0df5
2536330methyl salicylate 10 % Topical OintmentSYbf9060df-6886-6381-e053-2995a90aa0df5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73635-5804-37363558040385.5 mL in 1 JAR (73635-5804-3) 85.5 ml2019-03-290000-00-00NoNoCurrent