SU PHEDRINE PE

Product NDC: 57243-453
11-digit product format: 572430453
Labeler code: 57243
Product ID: 57243-453_5ae58203-4d1e-42ed-bbbe-e27aca71dc91
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Salado Sales, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-01-14
Marketing end: 2026-11-30
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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: SU PHEDRINE PE
Brand name suffix: Non-Drowsy, Maximum Strength

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1049182	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
9056fa58-d6aa-4df5-97e0-9be3f2332f86	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57243-453-44	SU PHEDRINE PENon-Drowsy, Maximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1		15
57243-453-44	SU PHEDRINE PENon-Drowsy, Maximum Strength	18 in 1 BLISTER PACK	TABLET, FILM COATED	18		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57243-453	SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20250117_9056fa58-d6aa-4df5-97e0-9be3f2332f86.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 142 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Foster and Thrive Adult Tussin DM MAX	DEXTROMETHORPHAN HBR, GUAIFENESIN	Strategic Sourcing Services LLC	5f6e4d56-4a66-4dbd-97c8-550310dea358	2024-11-05	Warnings	Exact identifier application number: M012
Cough Drops Honey Lemon with Sugar	MENTHOL	Lidl US LLC	4ad9398f-7488-6eaf-e054-00144ff8d46c	2024-11-05	Warnings	Exact identifier application number: M012
rexall dm cough and congestion relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dolgencorp, LLC	906838b1-a742-4728-944d-42b687b8cd59	2024-11-05	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HBR, GUAIFENESIN	H E B	7c24c59c-7549-4c64-95f8-4bf755cd6f61	2024-11-05	Warnings	Exact identifier application number: M012
equate adult tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores Inc	3592e000-a6c6-47fe-8bb0-9341c65c2959	2024-11-05	Warnings	Exact identifier application number: M012
tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Walgreen Company	756794b0-8d3b-4732-947c-a407caf400e2	2024-11-05	Warnings	Exact identifier application number: M012
basic care tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Amazon.com Services LLC	c6863e31-e1b9-40ff-ae2e-4aec86b4acc0	2024-11-05	Warnings	Exact identifier application number: M012
topcare tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Topco Associates LLC	94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a	2024-11-05	Warnings	Exact identifier application number: M012
Childrens Sudafed PE NASAL DECONGESTANT	PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d	2024-11-04	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	164b2559-2d3f-431e-a03c-07e86731af5c	2024-11-04	Warnings	Exact identifier application number: M012
tussin severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	7cc2c136-d1b7-4658-99bb-73bb1d140261	2024-11-04	Warnings	Exact identifier application number: M012
dg health tussin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	a5d0ee70-d528-4a53-bf01-7bb13b364ed0	2024-11-04	Warnings	Exact identifier application number: M012
basic care tussin cf severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	bba9a17d-eb87-46f3-acee-c9dd34e5bfd4	2024-11-04	Warnings	Exact identifier application number: M012
topcare tussin cf max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	b553b7e6-933b-49e3-97d3-22a4643a04b9	2024-11-04	Warnings	Exact identifier application number: M012
dg health nasal original	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	fb209752-705a-4bb0-9298-8b70357f3911	2024-11-02	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	3c301993-642a-487c-96a2-ebc4ef90dc88	2024-11-02	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	1341744c-43c3-462b-b93c-1e46476fd935	2024-11-01	Warnings	Exact identifier application number: M012
Nighttime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	43784616-1afd-4ff7-8fee-6ac389f616a2	2024-11-01	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	28ef87e8-29e5-444d-b1f7-5c38a7f758d3	2024-11-01	Warnings	Exact identifier application number: M012
Good Sense Severe NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	0e3c36c9-d45b-41b9-891d-a42d854295f9	2024-11-01	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049182	phenylephrine HCl 10 MG Oral Tablet	PSN	9056fa58-d6aa-4df5-97e0-9be3f2332f86	15
1049182	phenylephrine hydrochloride 10 MG Oral Tablet	SCD	9056fa58-d6aa-4df5-97e0-9be3f2332f86	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57243-453-44	57243045344	1 BLISTER PACK in 1 CARTON (57243-453-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2005-01-14	2026-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVP 44-453-Delisted	Salado Sales, Inc. \| LNK International, Inc.	2025-08-22	HUMAN OTC DRUG LABEL	15