BRONCOLIN

Product NDC: 62583-001
11-digit product format: 625830001
Labeler code: 62583
Product ID: 62583-001_eb01be3e-e6ad-7793-e053-2995a90a44f7
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: LOZENGE
Route: ORAL
Labeler: BRONCOLIN, S.A. de C.V.
Application: M012
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-04-01
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 8 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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	62583-001		D	Discontinued by firm		2026-10-21
excluded package	package	62583-001	62583-001-16	D	Discontinued by firm		2026-10-21

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 · 22 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	62583-001-16	`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	62583-001-16	`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	62583-001-16	`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	62583-001-16	`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	62583-001-16	`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	62583-001-16	`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	62583-001-16	`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	62583-001-16	`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	62583-001-16	`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	62583-001-16	`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	62583-001-16	`367a005e9d99…`	`383a685ebd0f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.]	1
CITRIC ACID ACETATE	INACTIVE INGREDIENT	DSO12WL7AU	BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.]	1
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.]	1
EUCALYPTUS PIPERITA LEAF	INACTIVE INGREDIENT	4GG3SCZ7GT	BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.]	1
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.]	1
PROPOLIS WAX	INACTIVE INGREDIENT	6Y8XYV2NOF	BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.]	1
SAMBUCUS NIGRA FLOWER	INACTIVE INGREDIENT	07V4DX094T	BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.]	1
VERBASCUM DENSIFLORUM FLOWER	INACTIVE INGREDIENT	N7FC535Q3R	BRONCOLIN HERBAL EXTRACTS AND HONEY (MENTHOL) LOZENGE [BRONCOLIN, S.A. DE C.V.]	1

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 55 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
S2	RACEPINEPHRINE HYDROCHLORIDE	Nephron Pharmaceuticals Corporation	dd1b35c7-b23b-4b95-8162-df3d263fe32e	2026-01-26	Warnings	Exact identifier application number: M012
SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0d97c634-0975-42d5-8ade-2ed2018cfe9d	2026-01-26	Warnings	Exact identifier application number: M012
GOOD SENSE NIGHT TIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	L. Perrigo Company	cd68289b-3850-40c6-9439-aae0e2d7637d	2026-01-26	Warnings	Exact identifier application number: M012
Seacall Nasal Spray.	NASAL SPRAY	Guangdong Quadrant Ecological Technology Co., Ltd.	1f12618b-7461-fb47-e063-6294a90af753	2026-01-23	Warnings	Exact identifier application number: M012
daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ecf7d210-102c-4053-81f6-67116de6cf7b	2026-01-23	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	44f9255b-0bf9-4573-ac9c-410acb515bc2	2026-01-23	Warnings	Exact identifier application number: M012
Daytime cold and flu non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Meijer Distribution Inc	29caa3a7-7fe6-4134-a9b0-49bdb9280ca7	2026-01-23	Warnings	Exact identifier application number: M012
good neighbor pharmacy night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amerisource Bergen	e2b5c27e-ca5f-4503-a3ce-c86e1d8070a7	2026-01-23	Warnings	Exact identifier application number: M012
RAYO ACTIVE ICE	MENTHOL, CAMPHOR	Quimicas Handal de Centroamerica SA de CV	09e4a36b-020a-c5b1-e063-6394a90a3e31	2026-01-22	Warnings	Exact identifier application number: M012
DRX CHOICE NIGHTTIME COLD and FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Raritan Pharmaceuticals Inc.	f466fc0e-3384-4884-832e-99bf1fdcf899	2026-01-21	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR GUAIFENESIN	Strategic Sourcing Services LLC	84750bfb-9e94-40a3-b731-21799f5e4fd1	2026-01-20	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Amerisource Bergen	0b58990f-2246-408e-9365-51f56bb6766c	2026-01-20	Warnings	Exact identifier application number: M012
NightTime Cold and Flu Multi Symptom	ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	a8460fc9-2d08-4e5f-8dd3-5135ecda5923	2026-01-20	Warnings	Exact identifier application number: M012
Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Family Dollar Services Inc	0a651316-623e-41eb-ab3a-641f5d807425	2026-01-20	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Non Drowsy Day and Night Cold and Flu	WALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU	Walgreens	579c47c8-6366-4785-9680-d3986ce9641d	2026-01-19	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and Cold	WALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLD	Walgreens	dd61c9d3-0b70-450e-9525-282710b383cc	2026-01-19	Warnings	Exact identifier application number: M012
Sinus Severe Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	48bf7422-38ef-d4b4-e063-6294a90aa3ab	2026-01-19	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreens	fc670515-a820-4ea7-8786-8ae710798b31	2026-01-19	Warnings	Exact identifier application number: M012
Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	WALGREENS	9dece7b1-00b1-2499-e053-2a95a90a0be3	2026-01-19	Warnings	Exact identifier application number: M012
SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	2dba2bec-e0e3-4910-89c5-ebc093e05bec	2026-01-19	Warnings	Exact identifier application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62583-001-16	62583000116	16 LOZENGE in 1 BOX (62583-001-16)	16 lozenge	2014-04-01	0000-00-00	No	No	Current