Home NDC 59779-648 Severe Congestion and Cough
Product NDC 59779-648
11-digit product format 597790648
Labeler code 59779
Product ID 59779-648_934fba3f-b43f-4370-a165-75a4799443d4
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CVS Pharmacy
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-07-20
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 10; 200; 5 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 2027-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 Severe Congestion and Cough
Brand name suffix Multi-Symptom Maximum Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ 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 1372652 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 59779-648-01 Severe Congestion and CoughMulti-Symptom Maximum Strength 3 in 1 PACKAGE TABLET, FILM COATED 3 16 59779-648-01 Severe Congestion and CoughMulti-Symptom Maximum Strength 10 in 1 BLISTER PACK TABLET, FILM COATED 10 16 59779-648-95 Severe Congestion and CoughMulti-Symptom Maximum Strength 3 in 1 CARTON TABLET, FILM COATED 3 16 59779-648-95 Severe Congestion and CoughMulti-Symptom Maximum Strength 10 in 1 BLISTER PACK TABLET, FILM COATED 10 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 GUAIFENESIN ACTIVE MOIETY 495W7451VQ SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59779-648 SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY] 15 Current NDC, Legacy NDC, 4 package rows 20240704_707eb066-cdfc-444b-833a-9d6d133d48e4.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 100 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Freegells Cough Drops Menthol 80ct MENTHOL RL Albert & Son Inc. c96cc162-5908-4990-9dc1-3ce912844274 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL R.L. ALBERT & SON, INC bac77712-6197-4b30-a5f8-9b99eb9d7b5a 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL R.L. ALBERT & SON, INC 6842d766-ade6-40b2-831b-f4feac25c6db 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL RL Albert & Son Inc. 9f324ca1-0e2a-47e3-997e-2aaa68a85751 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 30ct MENTHOL R.L. ALBERT & SON, INC 2063a013-aa0b-465d-b04f-cfe2e70d749f 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 200ct MENTHOL R.L. ALBERT & SON, INC cd81488c-74d8-48d9-9c73-ff662a5cd4cd 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 80ct MENTHOL R.L. ALBERT & SON, INC 61deea94-d0a9-4563-926b-53f255a7c425 2025-10-08 Warnings Exact identifier application number: M012 FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS MENTHOL R.L. ALBERT & SON, INC c6b36350-386b-4346-bef0-a37ec11319c0 2025-10-08 Warnings Exact identifier application number: M012 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Strategic Sourcing Services LLC 3314b174-d5bb-4843-9288-9b9c5fce79d5 2025-10-08 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL CVS Pharmacy 22f55699-4922-4c05-bdf5-5844c7dd3ee5 2025-10-07 Warnings Exact identifier application number: M012 OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution DIPHENHYDRAMINE HCL MEDWISE LIFESCIENCES INC. 407b7cbb-7ebd-7b7e-e063-6394a90af501 2025-10-06 Warnings Exact identifier application number: M012 Quality Choice Medicated Chest Rub CAMPHOR, MENTHOL, EUCALYPTUS OIL Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc 2025-10-06 Warnings Exact identifier application number: M012 Halls Sugar Free Honey Lemon MENTHOL Mondelez Global LLC 2b19fdd2-8088-47f2-be20-f220a6b825fc 2025-10-06 Warnings Exact identifier application number: M012 Giltuss Childrens Cough and Chest Congestion DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Dextrum Laboratories, Inc 40802fb6-c1ec-d7b0-e063-6394a90ab423 2025-10-06 Warnings Exact identifier application number: M012 Giltuss Diabetic DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Dextrum Laboratories, Inc 3f64c81a-bbfc-4575-e063-6294a90a6ed7 2025-10-06 Warnings Exact identifier application number: M012 TexaClear Severe Cough, Cold and Flu CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN GM Pharmaceuticals, INC cb99e5b3-1908-43c9-b31f-d35e7ce58b44 2025-10-06 Warnings Exact identifier application number: M012 RoboHBr Cough SUPPRESSANT DEXTROMETHORPHAN HBR DXM Pharmaceutical, Inc 0af624ce-191f-45e1-882b-e8acb90cc77b 2025-10-06 Warnings Exact identifier application number: M012 RoboTablets DEXTROMETHORPHAN DXM Pharmaceutical, Inc b92cf698-032d-4d8d-b19c-456c6338b094 2025-10-06 Warnings Exact identifier application number: M012 SinuLief LORATADINE RoseWell Pharmaceuticals LLC 32619143-a782-3497-e063-6394a90aaaec 2025-10-06 Warnings Exact identifier application number: M012 STAHIST AD CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE Magna Pharmaceuticals, Inc. ccedbc38-2479-4c35-9f86-a9f29bcfab3f 2025-10-03 Warnings Exact identifier application number: M012
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 59779-648-01 59779064801 3 BLISTER PACK in 1 PACKAGE (59779-648-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2015-07-20 0000-00-00 No No Current 59779-648-95 59779064895 3 BLISTER PACK in 1 CARTON (59779-648-95) / 10 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2023-07-19 No No Current