Germa Manteca Ubre Plus (TIN)

Product NDC
73635-5805
11-digit product format
736355805
Labeler code
73635
Product ID
73635-5805_5d6d733e-efad-3607-e063-6394a90ad326
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate 10%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Germa Products, LLC
Application
M014
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 (TIN)
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 (TIN)
2023-05-09Manteca Ubre Plus (TIN)
2023-05-09Manteca Ubre Plus (TIN)
2023-01-30Manteca Ubre Plus (TIN)
2023-01-30Manteca Ubre Plus (TIN)
2023-01-30Manteca Ubre Plus (TIN)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73635-5805-3Germa Manteca Ubre Plus (TIN)85.5 mL in 1 CANOINTMENT85.57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73635-5805GERMA MANTECA UBRE PLUS (TIN) (METHYL SALICYLATE 10%) OINTMENT [GERMA PRODUCTS, LLC]6Current NDC, Legacy NDC, 1 package rows20241017_bf8f5e25-f765-ef71-e053-2a95a90a1251.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 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraSealDIMETHICONEBausch Health US, LLC2c8dc616-20c1-4d33-8a89-9bcdb22b35c82024-10-17WarningsExact identifier
application number: M014
fungoid tinctureMICONAZOLE NITRATEPedinol Pharmacal, Inc.250d0a66-01d1-4aba-8f24-4cb4ca529fda2024-10-17WarningsExact identifier
application number: M014
GenRx Anti-Bacterial GelALCOHOLPureTek Corporationa124e37e-1a44-212a-e053-2995a90a0af02024-10-01WarningsExact identifier
application number: M014
Hand Sanitizing with Lavender OilALCOHOLPureTek Corporationa75d25a7-1e23-717f-e053-2a95a90a6d932024-10-01WarningsExact identifier
application number: M014
Leader Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDECardinal Health, Inc.0022a174-8377-44af-84a9-31adb27de1312024-08-23WarningsExact identifier
application number: M014
Leader Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDECardinal Health 110 DBA Leader36c1408b-4287-4e9f-aa17-4f05add500382024-08-12WarningsExact identifier
application number: M014
Major Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDEMajor Pharmaceuticals513bf82e-a36f-49d0-ba74-c834fea4f3b52024-08-12WarningsExact identifier
application number: M014
Alcohol WipesWIPE EM ALCOHOL WIPESShaoxing Elite Bio-Tech Co., Ltd.1f373096-d3d5-af7f-e063-6394a90a3b552024-08-08WarningsExact identifier
application number: M014
Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDENuCare Pharmaceuticals,Inc.b55acec6-5a4d-08b7-e053-2995a90a0f742024-07-17WarningsExact identifier
application number: M014
BacitracinBACITRACINNuCare Pharmaceuticals,Inc.a526ae4b-baae-5d50-e053-2a95a90ae2932024-07-17WarningsExact identifier
application number: M014
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals, Inc.54241254-1d9a-346a-e054-00144ff8d46c2024-07-17WarningsExact identifier
application number: M014
Dr Sheffield Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals,Inc.5786a559-a387-120d-e053-2991aa0ab6472024-07-15WarningsExact identifier
application number: M014
CVS Health Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDECVS Pharmacy, Inc.42a22e06-1b66-4359-852c-7c39e1b3940a2024-06-24WarningsExact identifier
application number: M014
TolnaftateTOLNAFTATENuCare Pharmaceuticals,Inc.63665de7-8415-651f-e053-2991aa0ac2bb2024-06-06WarningsExact identifier
application number: M014
Rite Aid Earwax Removal DropsCARBAMIDE PEROXIDERite Aid1262531e-0674-cf32-e063-6294a90a0d0b2024-05-10WarningsExact identifier
application number: M014
Debrox KidsISOPROPYL ALCOHOLMedtech Products Inc.f42eee70-c4ee-44ad-85d5-a06d98ecb8b02024-05-09WarningsExact identifier
application number: M014
Rite Aid Swimmers Ear DropsISOPROPYL ALCOHOLRite Aid12875b9d-3ae8-bd0c-e063-6294a90ab4ae2024-02-29WarningsExact identifier
application number: M014
Topcare Swimmers Ear DropsISOPROPYL ALCOHOLTopco Associates LLC0fddeb43-fee0-d43c-e063-6394a90a738a2024-01-26WarningsExact identifier
application number: M014
NeilMed Clear Canal Earwax Removal kitCARBAMIDE PEROXIDENEILMED PHARMACEUTICALS INCd330552d-07b6-f01e-e053-2a95a90a7ca52024-01-11WarningsExact identifier
application number: M014
Wax Out PlusCARBAMIDE PEROXIDE DROPSNEILMED PHARMACEUTICALS INCcf64f4b8-279c-8c1d-e053-2995a90ac8532024-01-11WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2536330methyl salicylate 10 % Topical OintmentPSNbf8f5e25-f765-ef71-e053-2a95a90a12517
2536330methyl salicylate 0.1 MG/MG Topical OintmentSCDbf8f5e25-f765-ef71-e053-2a95a90a12517
2536330methyl salicylate 10 % Topical OintmentSYbf8f5e25-f765-ef71-e053-2a95a90a12517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73635-5805-37363558050385.5 mL in 1 CAN (73635-5805-3) 85.5 ml2019-03-290000-00-00NoNoCurrent