Home NDC 57243-506 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.
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 Uploaded 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 54 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NOTTS - Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE VIVUNT PHARMA LLC e6754f62-e3b2-773f-e053-2a95a90ad36a 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN AAA Pharmaceutical, Inc. a891896d-c9fa-4448-915a-e6b531157d22 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN SAFEWAY d2d15e06-e9eb-3d2b-e053-2995a90a1cec 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Regular Strength ACETAMINOPHEN TopCo Associates LLC c2d33352-431c-4683-a4fa-a54437e7b8d2 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN TopCo Associates LLC bdb01b3e-ad34-4003-9b9a-e83a2c0e90bb 2024-12-02 Warnings Exact identifier application number: M013 Aspirin 81mg Adult Low Dose ASPIRIN TopCare 14d010fb-c4a1-4c3d-942f-58719727bfc0 2024-12-02 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS Pharmacy, Inc c4473ee6-4e01-1ec2-e053-2995a90ac513 2024-12-02 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Proficient Rx LP 9c186289-e309-45e8-8934-1d0eae0375c2 2024-12-01 Warnings Exact identifier application number: M013 Childrens Chewable Acetaminophen ACETAMINOPHEN GERI-CARE PHARMACEUTICAL CORP 22f63d62-c941-5b8f-e063-6394a90aeecd 2024-11-28 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Geri-Care Pharmaceutical Corp 7a7b6318-b7d6-31b1-e053-2991aa0abf25 2024-11-28 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL INGLES MARKETS, INC. 27fd288e-c07a-617f-e063-6394a90a17a4 2024-11-28 Warnings Exact identifier application number: M013 BAYER Aspirin Original, TRAVEL BASIX ASPIRIN Lil' Drug Store Products, Inc. 7f5d9ebe-8119-49a2-9380-eca18a5e5e85 2024-11-27 Warnings Exact identifier application number: M013 EXCEDRIN MIGRAINE ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE Jones Healthcare Group - Packaging Services, Inc c4168e4d-3dfc-4e51-a32e-14704cb59c66 2024-11-27 Warnings Exact identifier application number: M013 TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief ACETAMINOPHEN, LIDOCAINE, MENTHOL Kenvue Brands LLC 2611e984-0dd5-bda1-e063-6394a90a559a 2024-11-26 Warnings Exact identifier application number: M013 First Aid Only Extra-Strength Non-Aspirin ACETAMINOPHEN Acme United Corporation 6891d57a-10a6-53de-e053-2a91aa0ac7c2 2024-11-26 Warnings Exact identifier application number: M013 Chewable Aspirin ASPIRIN MARC GLASSMAN, INC. c8314910-71ff-5a55-e053-2995a90aafc7 2024-11-26 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Marc Glassman, Inc. 7990ca49-fb30-40fe-9ac4-48e89eac9bb2 2024-11-26 Warnings Exact identifier application number: M013 Enteric Coated Aspirin Regular Strength ASPIRIN Safeway 96359eb6-62bc-4b13-960c-050af99a8c02 2024-11-26 Warnings Exact identifier application number: M013 ASPIRIN Low Dose ASPIRIN Marc Glassman, Inc. 3d519af3-9398-4439-8253-1e5d4612b8e3 2024-11-26 Warnings Exact identifier application number: M013 ACETAMINOPHEN (RED) ACETAMINOPHEN Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 06eabf4b-f8c0-439a-acf1-aa6e3075c717 2024-11-25 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# 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