Home NDC 41226-628-16 ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL
Product NDC 41226-628
Requested package NDC 41226-628-16
11-digit product format 412260628
Labeler code 41226
Product ID 41226-628_2e2b687e-f62a-8485-e063-6294a90ab140
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Kroger Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-12-21
Substance PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 5; 325; 10; 200 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 2026-12-31
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 41226-628 41226-628-16 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 41226-628 41226-628-16 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 41226-628 41226-628-16 U Excluded because listing certification expired excluded / ndc_excluded.zip 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 ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1656815 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41226-628-16 ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL 16 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 16 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41226-628 ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL CAPSULE, LIQUID FILLED [KROGER COMPANY] 4 Current NDC, Legacy NDC, 1 package rows 20250217_a24f09d9-60f1-853a-e053-2a95a90ae1fa.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 17 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GOOD NEIGHBOR PHARMACY Childrens Allergy Relief DIPHENHYDRAMINE HCL AMERISOURCE BERGEN c499574c-f32b-4608-bf8b-51ad44e35725 2026-07-13 Warnings Exact identifier application number: M012 Good NeighborChildrens Allergy Relief Bubblegum flavor DIPHENHYDRAMINE HCL AMERISOURCE BERGEN f442c61b-7d2c-401c-b862-acbe2282927b 2026-07-13 Warnings Exact identifier application number: M012 Sanatos MENTHOL Pharmadel LLC 5683b099-f029-2d08-e063-6394a90ad482 2026-07-13 Warnings Exact identifier application number: M012 Cold and Flu Relief Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) f673cdeb-4f8b-46b4-be92-c725d74abc55 2026-07-13 Warnings Exact identifier application number: M012 Cold Multi-Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ARMY AND AIR FORCE EXCHANGE SERVICE e4fca5ba-2d45-4c38-b0fd-297159d1705a 2026-07-13 Warnings Exact identifier application number: M012 Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion DEXTROMETHORPHAN HBR, GUAIFENESIN AMERISOURCE BERGEN 0269c0fd-0d8f-4264-9025-d4dcb3c45c60 2026-07-13 Warnings Exact identifier application number: M012 Propolis Cooling Relief Cherry Cough Drops MENTHOL, UNSPECIFIED FORM Beekeeper's Naturals USA Inc 7087566d-f24a-4508-aa25-7f42d055c43e 2026-07-13 Warnings Exact identifier application number: M012 Sinus Pressure and Congestion Relief DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL Rite Aid Corporation 35bcf263-3296-4d9c-84c0-146a173d6e87 2026-07-13 Warnings Exact identifier application number: M012 Good Neighbor Childrens Cough Relief Cherry Flavor DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN AMERISOURCE BERGEN a8e2fd43-b801-41ae-8d79-8ecf4a771543 2026-07-13 Warnings Exact identifier application number: M012 Good Neighbor No Drip Nasal Mist Extra Moisturizing OXYMETAZOLINE HYDROCHLORIDE AMERISOURCE BERGEN 7872aadd-b23c-431f-8048-24eece25ca2d 2026-07-13 Warnings Exact identifier application number: M012 Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN AMERISOURCE BERGEN 404a3521-8340-4476-a068-0e69cd0e514f 2026-07-13 Warnings Exact identifier application number: M012 Daytime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab5 2026-07-13 Warnings Exact identifier application number: M012 Good Neighbor Long Acting Cough Adult Tussin DEXTROMETHORPHAN HBR AMERISOURCE BERGEN df3c76bd-bd5b-42d7-a5f1-560fd3cba646 2026-07-13 Warnings Exact identifier application number: M012 Good Neighbor Adult Tussin Mucus and chest congestion GUAIFENESIN AMERISOURCE BERGEN 97e9cd18-dd55-4a26-80e3-4c17b9e1a1e8 2026-07-13 Warnings Exact identifier application number: M012 GOOD NEIGHBOR PHARMACY No Drip Nasal Mist OXYMETAZOLINE HYDROCHLORIDE AMERISOURCE BERGEN a217ca8a-1c00-4816-bc26-cc0f71c80c90 2026-07-13 Warnings Exact identifier application number: M012 Severe Congestion and Cough DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Walgreen Company 1ddc04fb-069c-44fe-814b-ba4f503c4be0 2026-07-10 Warnings Exact identifier application number: M012 COUGH DROPS- menthol granule MENTHOL GRANULE Anhui Jiuhe Health Industry Co., Ltd 5351b943-5830-e4e7-e063-6394a90a5b66 2026-07-10 Warnings Exact identifier application number: M012 ValuMeds Nasal Decongestant PE Phenylephrine PHENYLEPHRINE HYDROCHLORIDE Cabinet Health P.B.C. 3f284420-87c1-4c17-99e5-bc569bf9d45f 2026-07-10 Warnings Exact identifier application number: M012 Severe Congestion and Cough Multi-Symptom Maximum Strength DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL CVS Pharmacy 707eb066-cdfc-444b-833a-9d6d133d48e4 2026-07-10 Warnings Exact identifier application number: M012 Sinus Congestion PHENYLEPHRINE HCL L.N.K. International, Inc. 81f0276a-99a2-4a57-a0d8-224735aa8c79 2026-07-10 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 41226-628-16 41226062816 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (41226-628-16) 2020-12-21 0000-00-00 No No Current