Menthol Cough Drops

Product NDC: 41250-082
11-digit product format: 412500082
Labeler code: 41250
Product ID: 41250-082_463d4e44-7500-ddde-e063-6294a90a3a7a
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: LOZENGE
Route: ORAL
Labeler: Meijer Distribution Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-06-09
Substance: MENTHOL
Active strength: 5.4 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	41250-082		D	Discontinued by firm		2026-10-16
excluded package	package	41250-082	41250-082-30	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41250-082-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41250-082-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	41250-082-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	41250-082-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	41250-082-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	41250-082-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41250-082-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41250-082-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	41250-082-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	41250-082-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	41250-082-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	41250-082-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Menthol Cough Drops
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	5.4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
485287	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3bee752a-4141-1f5b-e054-00144ff8d46c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41250-082-00	Menthol Cough Drops	200 in 1 BAG	LOZENGE	200		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-082	MENTHOL COUGH DROPS (MENTHOL) LOZENGE [MEIJER DISTRIBUTION INC.]	8	Current NDC, Legacy NDC, 1 package rows	20241202_3bee752a-4141-1f5b-e054-00144ff8d46c.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 96 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quantum Health Bing Cherry Flavor	MENTHOL, UNSPECIFIED FORM	Quantum, Inc.	94d40c95-fa2b-42cf-b9f5-a5027d86401d	2025-10-20	Warnings	Exact identifier application number: M012
Quantum Health Meyer Lemon and Honey Flavor	MENTHOL, UNSPECIFIED FORM	Quantum, Inc.	fe780067-5a20-4d55-a108-91237cd9e5f4	2025-10-20	Warnings	Exact identifier application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)	DIPHENHYDRAMINE HCL	MEDWISE LIFESCIENCES INC.	4157e680-37ac-eb4c-e063-6394a90a2a99	2025-10-17	Warnings	Exact identifier application number: M012
Norel AD	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL	U.S. PHARMACEUTICAL CORPORATION	53d9ed3c-212d-4b12-ac35-8bd49382b49d	2025-10-17	Warnings	Exact identifier application number: M012
Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	92c570ff-139f-49ff-a7bd-8a540ecc07c7	2025-10-17	Warnings	Exact identifier application number: M012
NoHist DM	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Larken Laboratories, Inc.	6aafe912-28ff-442f-8e07-b3c5993ac943	2025-10-16	Warnings	Exact identifier application number: M012
Signature Care Original	OXYMETAZOLINE HYDROCHLORIDE	SAFEWAY, INC.	f7ad687b-dcaf-928c-e053-6294a90a6abe	2025-10-16	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	90ccb29c-9967-46cb-a409-e440344e1a1a	2025-10-15	Warnings	Exact identifier application number: M012
Robitussin Childrens Honey Day Night DM Value Pack	DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	f9999875-3433-4052-a628-39539d373216	2025-10-15	Warnings	Exact identifier application number: M012
Robitussin Day and Night Cough Relief Value Pack	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	Haleon US Holdings LLC	4029eccd-5443-4ae2-9232-2a1d922798f8	2025-10-15	Warnings	Exact identifier application number: M012
EndaCof DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Larken Laboratories, Inc.	c68ea55a-8b9a-4a70-8b5c-1a2736651813	2025-10-15	Warnings	Exact identifier application number: M012
DURATUSS DM	DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	413a3951-d704-f14b-e063-6394a90a06dc	2025-10-15	Warnings	Exact identifier application number: M012
LoHist DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Larken Laboratories, Inc.	29730dab-fa09-4351-9b36-0359ba4f7744	2025-10-15	Warnings	Exact identifier application number: M012
M-END DMX	DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	R. A. McNeil Company	ee1fae2e-3a21-4487-9989-c7620a4a7056	2025-10-15	Warnings	Exact identifier application number: M012
Chlo Tuss	CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	R.A. McNeil Company	43610aaa-8b94-40d5-ae09-3d75bd2317c8	2025-10-15	Warnings	Exact identifier application number: M012
Chlo Hist	CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE	R. A. McNeil Company	d046f4ba-5753-4ed5-a924-0b66fd116781	2025-10-15	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	6ca7372b-50c4-4b15-b133-fefa35525ade	2025-10-15	Warnings	Exact identifier application number: M012
Extra Strength Sinus Relief Nasal Decongestant	PHENYLEPHRINE HYDROCHLORIDE	CARDINAL HEALTH	0d8a009c-30b5-4f12-90bd-f8aa1110243f	2025-10-14	Warnings	Exact identifier application number: M012
Tussin DM Cough plus Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Cardinal Health 110, Inc. DBA LEADER	9d11f443-c93d-44e8-b5a3-2677b7b11212	2025-10-14	Warnings	Exact identifier application number: M012
Rompe Pecho SF	GUAIFENESIN	Efficient Laboratories, Inc.	31ff48fc-9603-413c-ab7c-2598b3e08f9c	2025-10-14	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485287	menthol 5.4 MG Oral Lozenge	PSN	3bee752a-4141-1f5b-e054-00144ff8d46c	9
485287	menthol 5.4 MG Oral Lozenge	SCD	3bee752a-4141-1f5b-e054-00144ff8d46c	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-082-00	41250008200	200 LOZENGE in 1 BAG (41250-082-00)	200 lozenge	2014-06-09	0000-00-00	No	No	Current