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
Ingredient	Strength
METHYL SALICYLATE	100 mg/mL

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73635-5805-3	Germa Manteca Ubre Plus (TIN)	85.5 mL in 1 CAN	OINTMENT	85.5		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73635-5805	GERMA MANTECA UBRE PLUS (TIN) (METHYL SALICYLATE 10%) OINTMENT [GERMA PRODUCTS, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20241017_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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EAR WAX RMVL Rite Aid	CARBAMIDE PEROXIDE 6.5%	Rite Aid	9e3cedcc-e523-2653-e053-2a95a90ad143	2023-12-15	Warnings	Exact identifier application number: M014
EarWax Removal Kit Rite Aid	CARBAMIDE PEROXIDE 6.5%	Rite Aid	da78ac58-6c1c-4fa9-baac-e9dec0241385	2023-12-15	Warnings	Exact identifier application number: M014
Otix Ear wax Removal System Ear wax and Bulb	CARBAMIDE PEROXIDE	Bell Pharmaceuticals, Inc.	15868798-28cd-4495-9baf-711e81ad8bdd	2023-12-14	Warnings	Exact identifier application number: M014
Otix Ear wax Removal Drops	CARBAMIDE PEROXIDE	Bell Pharmaceuticals, Inc.	0e70ab09-9360-4ab6-a1fe-6f82af392581	2023-12-14	Warnings	Exact identifier application number: M014
TopCare Earwax Removal Drops	CARBAMIDE PEROXIDE	Topco Associates LLC	c5b1ad0e-3712-40fd-afbe-54c0b5f1160b	2023-12-14	Warnings	Exact identifier application number: M014
DG Health Earwax Removal kit	CARBAMIDE PEROXIDE 6.5%	DOLLAR GENERAL CORPORATION	4b6fc00f-72d7-4675-9881-b763f27c06e3	2023-12-07	Warnings	Exact identifier application number: M014
Ear Wax Removal Drops Equate	CARBAMIDE PEROXIDE - 6.5%	WALMART STORES INC	33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d	2023-12-04	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal Drops	CARBAMIDE PEROXIDE	Proficient Rx LP	a131447b-a5a0-45cd-a59c-a9f719275baa	2023-12-01	Warnings	Exact identifier application number: M014
Ear Wax Removal Drops	CARBAMIDE PEROXIDE - 6.5%	Sheffield Pharmaceuticals LLC	aad7e2cd-cb28-423c-a441-eabe6516d40f	2022-12-06	Warnings	Exact identifier application number: M014

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2536330	methyl salicylate 10 % Topical Ointment	PSN	bf8f5e25-f765-ef71-e053-2a95a90a1251	7
2536330	methyl salicylate 0.1 MG/MG Topical Ointment	SCD	bf8f5e25-f765-ef71-e053-2a95a90a1251	7
2536330	methyl salicylate 10 % Topical Ointment	SY	bf8f5e25-f765-ef71-e053-2a95a90a1251	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73635-5805-3	73635580503	85.5 mL in 1 CAN (73635-5805-3)	85.5 ml	2019-03-29	0000-00-00	No	No	Current