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 135 of 195 · 3,893 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vicks VapoSteam	CAMPHOR (SYNTHETIC)	Kaz USA, Inc	c28da455-07ad-4053-8b9e-fc559f9a3f72	2025-01-10	Warnings	Exact identifier application number: M012
Guaifenesin 200mg	GUAIFENESIN	Aphena Pharma Solutions - Tennessee, LLC	45ac210a-8c54-4469-8e10-e6fe52b89cb5	2025-01-09	Warnings	Exact identifier application number: M012
Meclizine HCL	MECLIZINE HCL 25MG CHEWABLE TABLETS	Aphena Pharma Solutions - Tennessee, LLC	02d1af4d-d97d-4019-a5bf-3ec391238676	2025-01-09	Warnings	Exact identifier application number: M012
HISTEX PD Drops New Formulation	TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	0c693f15-5d76-3dbf-e063-6294a90af9ac	2025-01-08	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HBR 15 MG	DEXTROMETHORPHAN HBR 15 MG	AMZ789 LLC	e2175017-6a0d-0155-e053-2995a90a65d6	2025-01-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR	Health Pharma USA LLC	29bb7822-76c6-e39d-e063-6294a90a64fb	2025-01-07	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	CHILDRENS ALLERGY RELIEF	Allegiant Health	cb6df361-b8e5-4e2f-945f-c20159d76c4f	2025-01-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength	PHENYLEPHRINE HCL	WinCo Foods, LLC	bb7a9fed-dc04-4c31-aa7f-4185d955242c	2025-01-06	Warnings	Exact identifier application number: M012
Leader Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Cardinal Health 110, LLC. dba Leader	207b2677-aaad-4fe4-a96d-963b7dcfba70	2025-01-06	Warnings	Exact identifier application number: M012
Allergy Relief Caplet	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	126c05e7-2cd9-47d3-96c3-82305714e1db	2025-01-02	Warnings	Exact identifier application number: M012
Right Remedies Adult Long Lasting Cough Relief Softgel	DEXTROMETHORPHAN HYDROBROMIDE	Strive Pharmaceuticals Inc.	e3ea468e-4e12-4dae-b222-8e32456b77b8	2025-01-02	Warnings	Exact identifier application number: M012
AVON HeXashield Congestion Relief Original	OXYMETAZOLINE HYDROCHLORIDE	Tai Guk Pharm. Co., Ltd.	8f2c152c-c564-0cba-e053-2a95a90ab3c7	2025-01-01	Warnings	Exact identifier application number: M012
Multi-Symptom Nighttime Cold and Flu Relief	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR	Advanced Rx LLC	a75553bd-f3f0-47bd-b3c3-aeeb0d1a81b4	2025-01-01	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE	Advanced Rx LLC	297e10e3-e740-4434-91a2-2e5c54985d33	2025-01-01	Warnings	Exact identifier application number: M012
MUCUS RELIEF DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Advanced Rx LLC	64620186-a45b-4c35-a3b9-a347348f93f7	2025-01-01	Warnings	Exact identifier application number: M012
DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Best Choice	57a44bbf-a304-47b9-8adc-4442c7787853	2025-01-01	Warnings	Exact identifier application number: M012
Long Acting Cough Softgels	DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY, INC	322daee6-c61d-43d3-a54d-a354fd3df242	2025-01-01	Warnings	Exact identifier application number: M012
Adult Tussin DM Lil Drug Store Products	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Lil' Drug Store Products, Inc	1915cf2a-ebaa-4c47-8991-5b741fa01be2	2024-12-31	Warnings	Exact identifier application number: M012
Congestion Relief Lil Drug Store Products	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	8fca348c-ecb6-4a91-89dd-8bd4c05ac745	2024-12-31	Warnings	Exact identifier application number: M012
Benadryl Ultra Tab	DIPHENHYDRAMINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	17633c87-ff0f-4fde-ab23-bc43bdc3fa8e	2024-12-31	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