SUPRESS-PE

Product NDC: 52083-056
11-digit product format: 520830056
Labeler code: 52083
Product ID: 52083-056_e99c9cb7-48a2-4115-8c61-4f7a0a9942bf
Type: HUMAN OTC DRUG
Nonproprietary name: Guiafenesin, Phenylephrine HCl
Dosage form: SOLUTION/ DROPS
Route: ORAL
Labeler: Kramer Novis
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-01-14
Substance: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 50; 2.5 mg/mL; mg/mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
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 · 14 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
2025-04-01 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	52083-056-01	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	52083-056-01	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	52083-056-01	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	52083-056-01	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	52083-056-01	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	52083-056-01	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	52083-056-01	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: SUPRESS-PE
Brand name suffix: Pediatric
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	50 mg/mL
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
824600	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
a474171d-5c29-4a80-9d37-00613796211a	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
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
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
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
52083-056-01	2025-04-22	C162847	48780-1	2cef2736-b234-d83d-e063-dadaa90ab31f	SUPRESS ® PE PEDIATRIC DROPS
52083-056-01	2025-01-30	C162847	48780-1	2cef2736-b234-d83d-e063-dadaa90ab31f	SUPRESS ® PE PEDIATRIC DROPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-056-01	SUPRESS-PEPediatric	30 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-056-01	ML - Milliliter	52083-056	64565411-aea5-49ec-874c-a8d98bf894b2	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-056	SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]	4	Current NDC, Legacy NDC, 1 package rows	20250424_a474171d-5c29-4a80-9d37-00613796211a.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 120 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AXIV DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	131b1f17-cd86-f9b3-e063-6294a90a3028	2025-02-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Topco Associates, LLC	17d0dbc7-c8c2-7917-e063-6394a90a42af	2025-02-12	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU	DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Kroger Company	bc00bbf8-52bb-fa75-e053-2a95a90a9406	2025-02-11	Warnings	Exact identifier application number: M012
Daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELS	TIME CAP LABORATORIES, INC.	fd24653e-c4fa-3c09-e053-6394a90aaa9e	2025-02-10	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELS	TIME CAP LABORATORIES INC.	fd81dd4b-9617-f4c1-e053-6394a90a5e72	2025-02-10	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	DOLGENCORP, LLC	be2207b7-b8f8-7fba-e053-2a95a90abd16	2025-02-10	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE	Kroger Company	bc0115a3-5322-855d-e053-2995a90aba27	2025-02-10	Warnings	Exact identifier application number: M012
Day time high blood pressure cold and flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR	Camber Consumer Care	09fbd872-0970-4864-9308-4a7b85983920	2025-02-10	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f05e11ce-c908-acbc-e053-2a95a90a584e	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f035c499-cda6-fadf-e053-2995a90af457	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f6d977ce-bbca-f1cc-e053-6394a90acc96	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f6da36d3-496d-2336-e053-6394a90a0f83	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f6da2e02-42c7-1ede-e053-6394a90aff5f	2025-02-09	Warnings	Exact identifier application number: M012
MUCOSA DM	GUAIFENESIN DEXTROMETHORPHAN	TIME CAP LABORATORIES, INC.	62c1f4aa-6571-414c-9a58-31e107b7db97	2025-02-08	Warnings	Exact identifier application number: M012
Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Genexa Inc.	2d95d5a4-34dc-e195-e063-6394a90a39da	2025-02-07	Warnings	Exact identifier application number: M012
Halls Sugar Free Honey Lemon	MENTHOL	Mondelez Global LLC	5d56ccd2-1c28-4750-9454-44809091ad2f	2025-02-05	Warnings	Exact identifier application number: M012
SanaTos Mucus Relief Cold Toddlers	DEXTROMETHORPHAN HBR, GUAIFENESIN	Pharmadel LLC	60672feb-1421-651e-e053-2a91aa0af41d	2025-02-04	Warnings	Exact identifier application number: M012
SofSkin Vaporizing Chest Rub and Cough Suppressant	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Viny Health and Beauty Inc	34626cf5-64fc-15c0-e063-6294a90aa310	2025-02-04	Warnings	Exact identifier application number: M012
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	CVS PHARMACY, INC	17922df7-7867-4300-bd99-55aee7b60606	2025-02-04	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	CVS Health	f4b8ff54-47b5-4d18-bf4e-b101abb22a24	2025-02-03	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
824600	guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution	PSN	a474171d-5c29-4a80-9d37-00613796211a	4
824600	guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution	SCD	a474171d-5c29-4a80-9d37-00613796211a	4
824600	guaifenesin 50 MG / phenylephrine HCl 2.5 MG per 1 ML Oral Solution	SY	a474171d-5c29-4a80-9d37-00613796211a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-056-01	52083005601	30 mL in 1 BOTTLE, DROPPER (52083-056-01)	30 ml	2014-01-14	0000-00-00	No	No	Current