M-END

Product NDC: 12830-816
11-digit product format: 128300816
Labeler code: 12830
Product ID: 12830-816_413d30e9-616e-f896-e063-6394a90acebc
Type: HUMAN OTC DRUG
Nonproprietary name: Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: R. A. McNeil Company
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-10-13
Substance: DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: .667; 10; 20 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 6 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
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	12830-816-16	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	12830-816-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	12830-816-16	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	12830-816-30	`fb8cb913e6d1…`	`eb8c232b6be0…`

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: M-END
Brand name suffix: DMX
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXBROMPHENIRAMINE MALEATE	.667 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE	20 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BPA9UT29BS	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1190600	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
ee1fae2e-3a21-4487-9989-c7620a4a7056	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
12830-816-16	2024-03-19	M-END DMX
12830-816-16	2024-03-19	M-END DMX
12830-816-30	2024-03-19	M-END DMX
12830-816-30	2024-03-19	M-END DMX
12830-816-16	2024-01-30	M-END DMX
12830-816-16	2024-01-30	M-END DMX
12830-816-30	2024-01-30	M-END DMX
12830-816-30	2024-01-30	M-END DMX
12830-816-16	2022-12-22	M-END DMX
12830-816-16	2022-12-22	M-END DMX
12830-816-30	2022-12-22	M-END DMX
12830-816-30	2022-12-22	M-END DMX
12830-816-16	2022-07-29	M-END DMX
12830-816-16	2022-07-29	M-END DMX
12830-816-30	2022-07-29	M-END DMX
12830-816-30	2022-07-29	M-END DMX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
12830-816-16	M-ENDDMX	473 mL in 1 BOTTLE	LIQUID	473		9
12830-816-30	M-ENDDMX	30 mL in 1 BOTTLE	LIQUID	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
12830-816-16	ML - Milliliter	12830-816	7caf2d65-b241-4862-9fda-e1c89f90c2c2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dexbrompheniramine Maleate	ACTIVE INGREDIENT	BPA9UT29BS	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
Pseudoephedrine Hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
Dexbrompheniramine	ACTIVE MOIETY	75T64B71RP	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
Sorbitol	INACTIVE INGREDIENT	506T60A25R	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
Sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12830-816	M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]	8	Current NDC, Legacy NDC, 2 package rows	20240321_ee1fae2e-3a21-4487-9989-c7620a4a7056.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 89 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
G-Supress DX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	5dd44337-f3aa-4e73-a206-4a29850a2f7c	2025-11-12	Warnings	Exact identifier application number: M012
Allergy Relief Complete	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	15b3de6c-7ccc-408b-8789-d0e2f21a8835	2025-11-12	Warnings	Exact identifier application number: M012
PRESGEN PEDIATRIC	GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE	KRAMER NOVIS	12fb91e5-6059-4b3a-a2de-762aa51a25b7	2025-11-12	Warnings	Exact identifier application number: M012
Sorbugen	DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE	Kramer Novis	a8f2a2d7-0360-45a8-9635-c852f4a7d7ba	2025-11-12	Warnings	Exact identifier application number: M012
DESGEN DM	DEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCL	Kramer Novis	6ab47174-e1fd-47ce-8788-06b7cdad5218	2025-11-12	Warnings	Exact identifier application number: M012
Presgen	GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Kramer Novis	edad7a86-0d27-4a98-85b2-4b6725904f28	2025-11-12	Warnings	Exact identifier application number: M012
TUSICOF	DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE	Kramer Novis	e966b75c-4bb4-4216-8247-baada8f5d759	2025-11-12	Warnings	Exact identifier application number: M012
Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	52327ed0-ea49-4d1c-b928-20ab381be9f2	2025-11-11	Warnings	Exact identifier application number: M012
TOPCO Childrens Cough Relief	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Topco Associates, LLC	ee0f5627-5104-4990-88ee-2fb46965bc1e	2025-11-11	Warnings	Exact identifier application number: M012
TOPCARE Childrens Cold and Cough and Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates, LLC	8931d4ca-c599-49be-87e1-8c0598f38b77	2025-11-11	Warnings	Exact identifier application number: M012
TOPCARE Multi Symptom Flu Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Topco Associates, LLC	01c517e5-d693-4926-9eb5-4b894a2f6917	2025-11-11	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	435b4a2a-d6bf-ec25-e063-6294a90a3f06	2025-11-11	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	435e6387-1ee0-c20f-e063-6294a90adac5	2025-11-11	Warnings	Exact identifier application number: M012
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b	2025-11-10	Warnings	Exact identifier application number: M012
TOPCARE Childrens Allergy Chews	DIPHENHYDRAMINE HCL	Topco Associates, LLC	b5e15dd1-6e99-411c-9183-8a4265eae404	2025-11-08	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE	Shield Pharmaceuticals Corp	103de130-ef12-4c58-bbcf-234b3f3b2cbf	2025-11-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Strawberry 30ct	MENTHOL	Dollar General Corporation	2b3fbab9-92b5-42a7-b27b-ff46350ce055	2025-11-07	Warnings	Exact identifier application number: M012
Robitussin Day and Night Maximum Strength Cough DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	b43d8fbd-1977-4465-aa64-79e7b7f54e09	2025-11-07	Warnings	Exact identifier application number: M012
Allergy plus Sinus Headache	ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG	Shield Pharmaceuticals Corp	093649a4-f968-49bd-83af-bb7e0f448ecf	2025-11-07	Warnings	Exact identifier application number: M012
TARGET Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	TARGET CORPORATION	bfc91c71-0506-4e94-8bfe-dc9e4bf959da	2025-11-07	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BPA9UT29BS	DEXBROMPHENIRAMINE MALEATE	2391-03-9	DEXBROMPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1190600	dexbrompheniramine maleate 0.667 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 20 MG in 5 mL Oral Solution	PSN	ee1fae2e-3a21-4487-9989-c7620a4a7056	9
1190600	dexbrompheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 4 MG/ML Oral Solution	SCD	ee1fae2e-3a21-4487-9989-c7620a4a7056	9
1190600	dexbrompheniramine maleate 0.667 MG / dextromethorphan hydrobromide 10 MG / pseudoephedrine hydrochloride 20 MG per 5 ML Oral Solution	SY	ee1fae2e-3a21-4487-9989-c7620a4a7056	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12830-816-16	12830081616	473 mL in 1 BOTTLE (12830-816-16)	473 ml	2011-10-13	0000-00-00	No	No	Current
12830-816-30	12830081630	30 mL in 1 BOTTLE (12830-816-30)	30 ml	2011-10-13	0000-00-00	No	No	Current