PRESGEN PEDIATRIC

Product NDC: 52083-653
11-digit product format: 520830653
Labeler code: 52083
Product ID: 52083-653_6fa9d05a-47dd-4ede-b77b-ada155683617
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE
Dosage form: SYRUP
Route: ORAL
Labeler: KRAMER NOVIS
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-03-24
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 5; 75; 2.5 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	52083-653-16	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	52083-653-16	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	52083-653-16	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	52083-653-16	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	52083-653-16	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	52083-653-16	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	52083-653-16	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	52083-653-16	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Additional Listing Data#

Finished product: Yes
Brand name base: PRESGEN PEDIATRIC
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/5mL
GUAIFENESIN	75 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	2.5 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
1119541	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
12fb91e5-6059-4b3a-a2de-762aa51a25b7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52083-653-16	2025-11-18	C162847	48780-1	2cef2736-b102-d83d-e063-dadaa90ab31f	PRESGEN PEDIATRIC
52083-653-16	2025-01-30	C162847	48780-1	2cef2736-b102-d83d-e063-dadaa90ab31f	PRESGEN PEDIATRIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-653-16	PRESGEN PEDIATRIC	480 mL in 1 BOTTLE	SYRUP	480		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-653-16	ML - Milliliter	52083-653	ddb3af58-cd6b-4248-aca4-547fb564a1f3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-653	PRESGEN PEDIATRIC (GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]	5	Current NDC, Legacy NDC, 1 package rows	20221029_12fb91e5-6059-4b3a-a2de-762aa51a25b7.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 169 of 195 · 3,893 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sinus	PSEUDOEPHEDRINE HYDROCHLORIDE	Kroger Company	18812f2a-9b66-45a7-9631-123da6fd1c1f	2024-09-20	Warnings	Exact identifier application number: M012
Nasal	OXYMETAZOLINE HYDROCHLORIDE	CVS Pharmacy	8913f6d1-3764-4f9c-8695-b788ef1bbe79	2024-09-19	Warnings	Exact identifier application number: M012
Good Sense Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	930469c1-384c-4440-b3e6-9dcd674871c4	2024-09-19	Warnings	Exact identifier application number: M012
Cold and Flu Relief Multi Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WinCo Foods, LLC	89272d2d-5533-4ae8-865b-cb204cec6d65	2024-09-17	Warnings	Exact identifier application number: M012
Cold and Flu Relief Multi Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WinCo Foods, LLC	5791c1c7-f614-4940-a45a-6291742e1e22	2024-09-17	Warnings	Exact identifier application number: M012
nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	2affd44d-2125-4a1f-919c-c082e7644ea8	2024-09-17	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE	Advanced Rx LLC	fa1a4d86-87bb-0c50-e053-6394a90a56e2	2024-09-13	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Advanced Rx LLC	fa1b60b1-49cb-1211-e053-6394a90a0a46	2024-09-13	Warnings	Exact identifier application number: M012
nasal	PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	8db7df1c-46b5-49bd-9002-50b12d58001a	2024-09-13	Warnings	Exact identifier application number: M012
meijer Daytime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	1bdd7f8a-93ce-5309-e063-6294a90a91f0	2024-09-12	Warnings	Exact identifier application number: M012
Daytime Cough Congestion Nighttime Cold Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL	KinderFarms, LLC	f2113abf-c1a3-42a6-a25e-e30a31fcad95	2024-09-12	Warnings	Exact identifier application number: M012
oxymetazoline hcl	OXYMETAZOLINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	a1103cd8-344b-4a65-8a60-3c7be86d01a6	2024-09-11	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	L. Perrigo Company	276d7d3c-c4a7-4754-8845-c38f85aac5f7	2024-09-08	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Strategic Sourcing Services LLC	4ff5a4ae-9649-4a6d-a5f8-ca23efbbb479	2024-09-08	Warnings	Exact identifier application number: M012
equate nasal original	OXYMETAZOLINE HYDROCHLORIDE	Wal-Mart Stores Inc	7e40c9b8-e0b5-448a-a674-72388fbab189	2024-09-08	Warnings	Exact identifier application number: M012
Anefrin Nasal Original	OXYMETAZOLINE HYDROCHLORIDE	Walgreen Company	85b442dc-1703-4fef-948a-fad7cbe9f224	2024-09-07	Warnings	Exact identifier application number: M012
equaline nasal	OXYMETAZOLINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	07e0328e-1912-4f25-9e1e-9482d4665be0	2024-09-07	Warnings	Exact identifier application number: M012
Benadryl Allergy EXTRA STRENGTH	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	dd0a8069-18d8-5696-e053-2995a90a2f22	2024-09-06	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	PAI Holdings, LLC	88d0994c-4270-4408-8837-bd97510b2118	2024-09-06	Warnings	Exact identifier application number: M012
QCH Maximum Strength Mucus Relief 617	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Chain Drug Marketing Association Inc.	a1c5c15e-0f3a-47d3-b9ed-1e0018417514	2024-09-06	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
1119541	dextromethorphan HBr 5 MG / guaiFENesin 75 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	12fb91e5-6059-4b3a-a2de-762aa51a25b7	6
1119541	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 15 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	12fb91e5-6059-4b3a-a2de-762aa51a25b7	6
1119541	dextromethorphan hydrobromide 5 MG / guaifenesin 75 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	12fb91e5-6059-4b3a-a2de-762aa51a25b7	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-653-16	52083065316	480 mL in 1 BOTTLE (52083-653-16)	480 ml	2011-03-24	0000-00-00	No	No	Current