Poly-Vent DM

Product NDC: 50991-214
11-digit product format: 509910214
Labeler code: 50991
Product ID: 50991-214_46518b53-5ca9-c68b-e063-6394a90a4150
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin and Pseudoephedrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Poly Pharmaceuticals, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-06-17
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 20; 380; 60 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
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	50991-214-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50991-214-01	`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	50991-214-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50991-214-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

Additional Listing Data#

Finished product: Yes
Brand name base: Poly-Vent DM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	20 mg/1
GUAIFENESIN	380 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6V9V2RYJ8N	Internal UNII lookup
495W7451VQ	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1427998	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
739329ae-0b62-4eab-a07d-867b5d3d61e0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
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
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
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
76633df9-0d59-4b88-03ed-21dee1b966f8	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
50991-214-01	2025-12-09	Poly-Vent DM Tablets
50991-214-02	2025-12-09	Poly-Vent DM Tablets
50991-214-01	2025-07-29	Poly-Vent DM Tablets
50991-214-02	2025-07-29	Poly-Vent DM Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50991-214-01	Poly-Vent DM	100 in 1 BOTTLE	TABLET	100	12
50991-214-02	Poly-Vent DM	12 in 1 CARTON	TABLET	12	12
50991-214-02	Poly-Vent DM	1 in 1 POUCH	TABLET	1	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50991-214-01	EA - Each	50991-214	a373744a-2020-4395-a4a2-bbf667605f76	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]	4
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]	4
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]	4
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]	4
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]	4
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]	4
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50991-214	POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]	10	Current NDC, Legacy NDC, 3 package rows	20241109_739329ae-0b62-4eab-a07d-867b5d3d61e0.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 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	ce590997-3cae-4f22-ac39-2b14d39494bc	2026-07-30	Warnings	Exact identifier application number: M012
Robitussin Direct Cough	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	70c9556b-063a-4fb3-96f6-1d4ffa495ed4	2026-07-30	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a302e341-1c00-4c3d-b71f-c4c0b307aa67	2026-07-29	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	4c737cd6-fe56-4cef-887c-cd6cf83b254c	2026-07-29	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGHGELS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	472c5c1f-eb5a-444b-a17e-f0d71007fb15	2026-07-29	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer Distribution Inc	3a33c6ce-aada-4099-8c61-49c86c0fc1a8	2026-07-29	Warnings	Exact identifier application number: M012
Tussin DM Max Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	668c92ce-6c1f-4ab3-b0dd-822b0768cb5e	2026-07-29	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	702f9786-7ce9-43e4-921d-e1db09612127	2026-07-28	Warnings	Exact identifier application number: M012
LoHist-D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	efaa354e-c25c-405b-9d30-001c2796978c	2026-07-28	Warnings	Exact identifier application number: M012
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
Childrens Benadryl ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	fc9181b9-c92d-493e-8d7c-4a4239c6c092	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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1427998	dextromethorphan HBr 20 MG / guaiFENesin 380 MG / pseudoephedrine HCl 60 MG Oral Tablet	PSN	739329ae-0b62-4eab-a07d-867b5d3d61e0	12
1427998	dextromethorphan hydrobromide 20 MG / guaifenesin 380 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet	SCD	739329ae-0b62-4eab-a07d-867b5d3d61e0	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50991-214-01	50991021401	100 TABLET in 1 BOTTLE (50991-214-01)	100 tablet	2013-06-17	0000-00-00	No	No	Current
50991-214-02	50991021402	12 POUCH in 1 CARTON (50991-214-02) / 1 TABLET in 1 POUCH	12 pouch	2013-06-17	0000-00-00	No	No	Current