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 14 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d1115a55-35cd-4f20-8872-f42983a5ebcd	2026-07-28	Warnings	Exact identifier application number: M012
TUSSIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Safeway	a5e2bda4-2da6-4c20-855d-2888dadf0c3a	2026-07-28	Warnings	Exact identifier application number: M012
DM Maximum	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f6029b04-e681-40fc-be4f-14091b76dd4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	e958eef1-8aae-4365-ac64-95a9e8e7e0f2	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	38400854-27fa-e291-e063-6294a90a5c4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Better Living Brands, LLC	65802aa7-64e7-4435-ad6b-65895fba17ce	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	0a48f650-ad2a-4105-9ff4-2bc4d94b46d3	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	84202ebe-97b6-4be2-bb09-7f2729303f96	2026-07-27	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	8d41defe-8120-4cbb-b42e-c805cc5a794b	2026-07-24	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	3afc88c7-388a-dbd9-e063-6294a90a4faf	2026-07-24	Warnings	Exact identifier application number: M012
Giltuss Allergy Plus	CHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	85a0dc7f-ffb5-7d52-e053-2991aa0a602a	2026-07-23	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	8590fcc9-c0dd-f43b-e053-2991aa0a692e	2026-07-23	Warnings	Exact identifier application number: M012
Giltuss Sinus and Chest Congestion	GUAIFENESIN, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	8591003c-c2f2-df65-e053-2a91aa0a42fb	2026-07-23	Warnings	Exact identifier application number: M012
COLDTAC Plus	ACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	OPMX LLC	3496866c-682f-420b-bfdb-64ecebbf70a2	2026-07-23	Warnings	Exact identifier application number: M012
nighttime cough dm	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	5a45b4c2-6a15-40b4-9ac6-d1554244ec42	2026-07-23	Warnings	Exact identifier application number: M012
DAY TIME NITE TIME INTENSE FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	6372cbdd-a3a3-499d-91ce-53bcdb83e739	2026-07-23	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	df6e522c-3e30-4aa0-8ab9-3b579c80bcad	2026-07-22	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba	2026-07-22	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Kenvue Brands LLC	1c5386c1-e45d-9dcb-e063-6294a90aff07	2026-07-22	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	772d0184-8c41-40f1-bbef-7e68692eec66	2026-07-22	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