Presgen

Product NDC: 52083-632
11-digit product format: 520830632
Labeler code: 52083
Product ID: 52083-632_c3363889-6ee4-4e45-9233-712513223055
Type: HUMAN OTC DRUG
Nonproprietary name: guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide
Dosage form: SYRUP
Route: ORAL
Labeler: Kramer Novis
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-03-28
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10; 200; 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-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-1 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 · 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	52083-632-16	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	52083-632-16	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	52083-632-16	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	52083-632-16	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	52083-632-16	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	52083-632-16	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	52083-632-16	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	52083-632-16	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: Presgen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL
GUAIFENESIN	200 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1098647	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
edad7a86-0d27-4a98-85b2-4b6725904f28	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52083-632-16	2025-11-18	C162847	48780-1	2cef2736-8d88-d83d-e063-dadaa90ab31f	PRESGEN
52083-632-16	2025-01-30	C162847	48780-1	2cef2736-8d88-d83d-e063-dadaa90ab31f	PRESGEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-632-16	Presgen	480 mL in 1 BOTTLE	SYRUP	480		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-632-16	ML - Milliliter	52083-632	a971900b-09fd-4689-add7-97b8dc07d666	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-632	PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	4	Current NDC, Legacy NDC, 1 package rows	20221029_edad7a86-0d27-4a98-85b2-4b6725904f28.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 16 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	2cbf27b6-217c-46d8-89c9-e46f3668f002	2026-07-17	Warnings	Exact identifier application number: M012
Best Choice	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	d86d53cd-75ce-4c40-83cb-ada9b77a76f6	2026-07-17	Warnings	Exact identifier application number: M012
LEADER Multi Symptom Flu Relief Daytime Max Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CARDINAL HEALTH 110, LLC. DBA LEADER	2212cf9e-6944-4922-b5b5-1373cf10b2e1	2026-07-16	Warnings	Exact identifier application number: M012
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	CVS PHARMACY	06756130-1608-4ae6-9772-95a4549853a1	2026-07-16	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Old East Main Co.	7855033e-6a12-4cd8-b0a2-c5d69018d117	2026-07-16	Warnings, Adverse reactions	Exact identifier application number: M012
Oxymetazoline Hydrochloride 12-Hour	OXYMETAZOLINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	34a79f8b-32b7-48db-a895-c942cc795292	2026-07-16	Warnings	Exact identifier application number: M012
LoHist D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	93c9ad4f-3376-48c2-8276-0375663acd01	2026-07-16	Warnings	Exact identifier application number: M012
Sanatos	MENTHOL	Pharmadel LLC	522e1e7f-98ed-c475-e063-6294a90a622c	2026-07-16	Warnings	Exact identifier application number: M012
LEADER MS Flu Relief Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR	CARDINAL HEALTH 110, LLC. DBA LEADER	9db7d4e2-f7c1-41a7-8e1c-ef8d3512259d	2026-07-16	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	1bf4cd96-5800-434d-a0dc-e84c759ebb33	2026-07-16	Warnings	Exact identifier application number: M012
Mucus Relief Cough Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN	Walgreens	2ace231a-94c4-479d-bb26-454bd07b207b	2026-07-16	Warnings	Exact identifier application number: M012
LEADER No Drip	ALLERGY SINUS NASAL MIST	CARDINAL HEALTH 110, LLC. DBA LEADER	e7b2c1c1-6250-4af3-b131-22aced2b23d5	2026-07-16	Warnings	Exact identifier application number: M012
Mucus Relief DM Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Amerisource Bergen	639a59b7-ccff-485e-a232-38b680827229	2026-07-16	Warnings	Exact identifier application number: M012
Equate Nighttime Vapor Ice Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WALMART INC.	30470a01-4d42-44c6-a017-d68bb74cdef7	2026-07-15	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	1f93fe6d-ee21-e323-e063-6394a90a61bf	2026-07-15	Warnings	Exact identifier application number: M012
Pentrexcilina Daytime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b7b3c15a-bb28-5c25-e053-2a95a90ad3b1	2026-07-15	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	1f93c815-63c7-bfe0-e063-6394a90ab4a5	2026-07-15	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	5fa848ef-35ee-4e05-8ff2-781d034cf6ac	2026-07-14	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Cardinal Health 110, LLC. DBA Leader	0fad61d8-4393-47ec-9ff6-7df5be761f5b	2026-07-14	Warnings	Exact identifier application number: M012
Sinus and Allergy Relief PE	CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	Rite Aid Corporation	211c4273-3b2c-4169-b9c6-7a87903e77cd	2026-07-13	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
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1098647	dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 10 mL Oral Solution	PSN	edad7a86-0d27-4a98-85b2-4b6725904f28	5
1098647	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution	SCD	edad7a86-0d27-4a98-85b2-4b6725904f28	5
1098647	dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution	SY	edad7a86-0d27-4a98-85b2-4b6725904f28	5
1098647	dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 10 ML Oral Solution	SY	edad7a86-0d27-4a98-85b2-4b6725904f28	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-632-16	52083063216	480 mL in 1 BOTTLE (52083-632-16)	480 ml	2011-03-28	0000-00-00	No	No	Current