Daytime

Product NDC: 57243-506
11-digit product format: 572430506
Labeler code: 57243
Product ID: 57243-506_49c1c962-2dba-479b-b98a-a70e9d7dd68b
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form: LIQUID
Route: ORAL
Labeler: Salado Sales, Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-09-05
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], 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: 2027-12-31
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: Daytime
Brand name suffix: Non-Drowsy COLD/FLU
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE	5 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	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
1113705	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
e181b371-78c7-4163-865d-acc064be33ca	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57243-506-25	DaytimeNon-Drowsy COLD/FLU	177 mL in 1 BOTTLE	LIQUID	177		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57243-506	DAYTIME NON-DROWSY COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SALADO SALES, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20231230_e181b371-78c7-4163-865d-acc064be33ca.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 79 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Westminster Pharmaceuticals, LLC	ace5ebac-ec11-4c26-b1e3-954b450ee671	2021-05-04	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Allegiant Health	8cacf02c-9925-40d4-92bc-78788aa0681a	2020-11-11	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN 500 MG	Allegiant Health	8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7	2020-03-13	Warnings	Exact identifier application number: M013
Acetaminophen 500mg ES	ACETAMINOPHEN 500MG	Allegiant Health	91acc132-01b6-467b-9af5-70f4dc93e087	2019-01-08	Warnings	Exact identifier application number: M013
Acetaminophen 325mg RS	ACETAMINOPHEN 325MG	Allegiant Health	61c6d281-e59b-4277-bbce-f71c12c2a56d	2019-01-07	Warnings	Exact identifier application number: M013
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Allegiant Health	9a4c0c43-a71a-4e22-a3d5-9eb9622689a2	2019-01-02	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG	Allegiant Health	423a8445-964c-4cdb-889a-f391ca5253e7	2018-12-31	Warnings	Exact identifier application number: M013
Cold Multi-Symptom Night-time	ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI	Allegiant Health	3f020cf2-6011-4216-9b39-0b3dc5f0749c	2018-12-26	Warnings	Exact identifier application number: M013
Aspirin Chewable	ASPIRIN 81 MG	Allegiant Health	92b8637b-03a9-461f-b2f6-6eddaa214953	2018-12-21	Warnings	Exact identifier application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Allegiant Health	b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f	2018-12-21	Warnings	Exact identifier application number: M013
Clear Choice Regular Strength Pain Reliever	ACETAMINOPHEN	Athlete's Needs, Inc.	d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7	2018-12-11	Warnings	Exact identifier application number: M013
ASPIRIN Enteric Coated	ASPIRIN 81 MG	Allegiant Health	5910a882-eb40-440f-8a30-c21fbce9050e	2018-11-07	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN 325 MG	Allegiant Health	88b54062-8b3d-4024-a957-62b3255184b9	2018-11-07	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Allegiant Health	3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5	2018-11-07	Warnings	Exact identifier application number: M013
Tension Headache Relief	TENSION HEADACHE RELIEF	Allegiant Health	b431a1a3-39c4-4d6c-afdc-c8b017ad89da	2017-11-16	Warnings	Exact identifier application number: M013
SED-MAX	ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG	Command Brands, LLC	4920a0e9-6f88-4df0-8657-77c95a3b9617	2017-01-19	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	e181b371-78c7-4163-865d-acc064be33ca	5
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	e181b371-78c7-4163-865d-acc064be33ca	5
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	e181b371-78c7-4163-865d-acc064be33ca	5
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	e181b371-78c7-4163-865d-acc064be33ca	5
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	e181b371-78c7-4163-865d-acc064be33ca	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57243-506-25	57243050625	177 mL in 1 BOTTLE (57243-506-25)	177 ml	2012-09-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Daytime Non-Drowsy COLD/FLU - Salado Sales, Inc. \| AptaPharma Inc.	Salado Sales, Inc. \| AptaPharma Inc.	2023-12-29	HUMAN OTC DRUG LABEL	5