PECGEN DMX

Product NDC: 52083-630
11-digit product format: 520830630
Labeler code: 52083
Product ID: 52083-630_73a7e53a-91e6-4f2a-98f0-d73ba7995194
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin
Dosage form: SOLUTION
Route: ORAL
Labeler: KRAMER NOVIS
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-04-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 10; 187 mg/5mL; mg/5mL
Pharmacologic classes: 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]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52083-630-16	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52083-630-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52083-630-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52083-630-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52083-630-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52083-630-16	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52083-630-16	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52083-630-16	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: PECGEN DMX
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL
GUAIFENESIN	187 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1441364	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
a627824c-5e3d-4672-a047-6c801b50b432	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52083-630-16	2025-11-18	C162847	48780-1	2cef2736-8a63-d83d-e063-dadaa90ab31f	PECGEN ® DMX
52083-630-16	2025-01-30	C162847	48780-1	2cef2736-8a63-d83d-e063-dadaa90ab31f	PECGEN ® DMX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-630-16	PECGEN DMX	474 mL in 1 BOTTLE, PLASTIC	SOLUTION	474		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-630-16	ML - Milliliter	52083-630	d3358e56-bf8e-4654-bb6b-e3acb1fbb977	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	2
MENTHOL, UNSPECIFIED FORM	INACTIVE INGREDIENT	L7T10EIP3A	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	2
POLYETHYLENE GLYCOL 1000	INACTIVE INGREDIENT	U076Q6Q621	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-630	PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]	4	Current NDC, Legacy NDC, 1 package rows	20190920_a627824c-5e3d-4672-a047-6c801b50b432.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 139 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Poly-Vent IR	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	ce0d8c45-446a-4df4-a36b-5000ba69d30d	2024-11-09	Warnings	Exact identifier application number: M012
basic care tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amazon.com Services LLC	306d5914-03ed-410a-9345-c54ba604e991	2024-11-09	Warnings	Exact identifier application number: M012
care one nasal original	OXYMETAZOLINE HYDROCHLORIDE	American Sales Company	a0c35e06-c9e9-438e-8224-d4760b6e2aff	2024-11-09	Warnings	Exact identifier application number: M012
adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Walgreen Company	34174507-cf2e-4ed4-85ec-f915d4b910df	2024-11-08	Warnings	Exact identifier application number: M012
Childrens Benadryl Chewables	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	b08f71d8-a06c-41ba-8ed1-fbc41dbc1919	2024-11-08	Warnings	Exact identifier application number: M012
SUDAFED PE SINUS CONGESTION	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	a38fdfb8-db89-487f-9b68-aa9152b91f5f	2024-11-08	Warnings	Exact identifier application number: M012
SUDAFED Sinus Congestion	PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	c05d7e27-6821-468f-b27d-9c0b02a07b0f	2024-11-08	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	2884d2dc-2d4a-4ca6-ab73-688a80b428eb	2024-11-08	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night	ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATE	Kenvue Brands LLC	712ba011-79aa-469b-9f0f-04a0b4b705bd	2024-11-08	Warnings	Exact identifier application number: M012
SUDAFED PE Pressure Plus Pain	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	8538c291-9ce9-4866-b268-f4cbdb52f5bd	2024-11-08	Warnings	Exact identifier application number: M012
Childrens Sudafed Nasal Decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	52e9307b-ad38-4f65-bb2f-4fa262e82010	2024-11-08	Warnings	Exact identifier application number: M012
Benadryl Allergy Plus Congestion	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	685b51d3-cc25-47b2-ac8a-368924f43137	2024-11-08	Warnings	Exact identifier application number: M012
Sudafed PE Sinus Pressure Plus Pain	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	60183922-bfd3-4377-884a-51b2f0a4c93a	2024-11-08	Warnings	Exact identifier application number: M012
Sudafed PE Sinus Congestion	PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	2ca08917-1a75-4365-8520-c083e6a4225a	2024-11-08	Warnings	Exact identifier application number: M012
SUDAFED PE Head Congestion Plus Mucus	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	f0739186-41b9-4761-adf7-08101b30a18e	2024-11-08	Warnings	Exact identifier application number: M012
SUDAFED PE Head Congestion Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	1e528f78-0ced-4a06-935a-84056c921727	2024-11-08	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	657a1e59-104c-4152-b2c9-00a8b82dc78e	2024-11-08	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu Severe and Tylenol Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	47c61858-72ce-409b-a3af-a63620cf7d13	2024-11-08	Warnings	Exact identifier application number: M012
Childrens Benadryl Allergy Plus Congestion	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	b8b75904-3806-4258-89c1-d6ff486ed41c	2024-11-08	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	464de5de-0e7a-41d6-875f-dd0e5fe7893c	2024-11-08	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1441364	dextromethorphan HBr 10 MG / guaiFENesin 187 MG in 5 mL Oral Solution	PSN	a627824c-5e3d-4672-a047-6c801b50b432	5
1441364	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral Solution	SCD	a627824c-5e3d-4672-a047-6c801b50b432	5
1441364	dextromethorphan hydrobromide 10 MG / guaifenesin 187 MG per 5 ML Oral Solution	SY	a627824c-5e3d-4672-a047-6c801b50b432	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-630-16	52083063016	474 mL in 1 BOTTLE, PLASTIC (52083-630-16)	474 ml	2015-04-01	0000-00-00	No	No	Current