Home NDC 55758-415 Sanatos
Product NDC 55758-415
11-digit product format 557580415
Labeler code 55758
Product ID 55758-415_0a5fc0ef-ba33-bb0b-e063-6394a90af7d9
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr
Dosage form LIQUID
Route ORAL
Labeler Pharmadel LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength 20; 650 mg/30mL; mg/30mL
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 Sanatos
Brand name suffix Multi Symptom Daytime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL ACETAMINOPHEN 650 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2604561 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55758-415-06 SanatosMulti Symptom Daytime 177 mL in 1 BOTTLE, PLASTIC LIQUID 177 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-415 SANATOS MULTI SYMPTOM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) LIQUID [PHARMADEL LLC] 1 Current NDC, 1 package rows 20231201_0a5fc0ef-ba34-bb0b-e063-6394a90af7d9.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 26 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc f818417e-0b31-4fe7-8313-4160a00b248a 2025-12-22 Warnings Exact identifier application number: M013 CareALL Acetaminophen ACETAMINOPHEN New World Imports, Inc c4f82ed8-b82c-47bb-9ab9-108a13d29cf7 2025-12-22 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 5103450a-3095-49cc-9823-4fb4c1d258ff 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Non-Aspirin PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc 499b2bf8-72fb-4500-b16e-517cab09a8ae 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc 933154b9-c9d6-4260-8775-1c83631c74e4 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc c93aa5e4-3994-439f-8f14-4e81773ed4e2 2025-12-22 Warnings Exact identifier application number: M013 Acetaminophen Diphenhydramine HCl ACETAMINOPHEN DIPHENHYDRAMINE HCL Granules USA, Inc. 8c9f68e3-fedc-6457-e053-2995a90a045a 2025-12-22 Warnings Exact identifier application number: M013 Aspirin ASPIRIN L.N.K. International, Inc. 35005045-57b2-4ffe-ab70-22d570c1b161 2025-12-22 Warnings Exact identifier application number: M013 Tension Headache Relief ACETAMINOPHEN, CAFFEINE NUVICARE LLC ea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Walmart 175495fd-c561-f813-e063-6294a90aac80 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALMART INC 21b22e9f-b6d1-1819-e063-6294a90ae09c 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine HCL ACETAMINOPHEN AND DIPHENHYDRAMINE HCL SAFEWAY f18c1aa2-5f8b-5458-e053-2995a90ab947 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Meijer 181b3148-fa33-c650-e063-6294a90a0de6 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN TOPCO ASSOCIATES LLC 1a00a49e-f9ff-b928-e063-6394a90a4cb5 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PUBLIX SUPERMARKETS, INC 08f57305-0c4b-96b1-e063-6394a90a77df 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine HCL ACETAMINOPHEN AND DIPHENHYDRAMINE HCL PUBLIX SUPERMARKETS, INC 08f549cf-042a-7bf2-e063-6394a90a83ef 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALGREEN CO. b8a855ae-c0a3-0b05-e053-2a95a90ac8a8 2025-12-19 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Marc Glassman, Inc. f708e1ec-cf2a-4e2b-851f-f6b703f359b2 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALGREEN CO. b375de90-25c7-aa55-e053-2995a90a3cf8 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN TARGET CORPORATION e64a3c32-5466-0662-e053-2a95a90ae963 2025-12-19 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 Sample Exclude flag Status 55758-415-06 55758041506 177 mL in 1 BOTTLE, PLASTIC (55758-415-06) 177 ml 2023-12-01 No No Current