menthol cough drops

Product NDC: 36800-814
11-digit product format: 368000814
Labeler code: 36800
Product ID: 36800-814_466ef0c2-7238-1fe8-e063-6294a90ad070
Type: HUMAN OTC DRUG
Nonproprietary name: menthol
Dosage form: LOZENGE
Route: ORAL
Labeler: Topco Associates
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-03-22
Substance: MENTHOL
Active strength: 5.4 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
menthol cough drops	MENTHOL	Topco Associates	366cc6b1-beff-29d2-e054-00144ff88e88	2025-12-20	Warnings	Exact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

Additional Listing Data#

Finished product: Yes
Brand name base: menthol cough drops
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	5.4 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	L7T10EIP3A
Rxcui	485287

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-814-30	menthol cough drops	30 in 1 BAG	LOZENGE	30		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-814	MENTHOL COUGH DROPS (MENTHOL) LOZENGE [TOPCO ASSOCIATES]	8	Current NDC, Legacy NDC, 1 package rows	20241202_366cc6b1-beff-29d2-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485287	menthol 5.4 MG Oral Lozenge	PSN	366cc6b1-beff-29d2-e054-00144ff88e88	9
485287	menthol 5.4 MG Oral Lozenge	SCD	366cc6b1-beff-29d2-e054-00144ff88e88	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-814-30	36800081430	30 LOZENGE in 1 BAG (36800-814-30)	30 lozenge	2013-03-22	0000-00-00	No	No	Current