Home NDC 69729-782 Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
Product NDC 69729-782
11-digit product format 697290782
Labeler code 69729
Product ID 69729-782_5c3f62d2-aa68-6733-e063-6394a90a186a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler OPMX LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-02-18
Substance ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 200; 10; 5 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 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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69729-782-10 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69729-782-10 1332a3947898…d4bfe170f9cd…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69729-782-10 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69729-782-10 bd6a592717d7…303034d00443…
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, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 GUAIFENESIN 200 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2024-05-19 Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel) 2024-05-19 Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel) 2024-01-30 Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel) 2024-01-30 Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel) 2022-04-12 Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel) 2022-04-12 Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel) 2022-01-28 Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel) 2022-01-28 Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel)
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69729-782-10 Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-782 ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED [OPMX LLC] 4 Current NDC, Legacy NDC, 1 package rows 20240521_9a164cfc-b623-9a9f-e053-2a95a90a0173.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 131 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tussin Multi Symptom Cold CF DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE Best Choice (Valu Merchandisers Company) 539b8972-2a46-468e-ad27-6672d746feb7 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. db2ab9be-507d-4768-9d00-188f751b7726 2024-12-10 Warnings Exact identifier application number: M012 Adult Allergy Relief CALMCO ALLERGY RELIEF CalmCo 08288825-0f38-b6a3-e063-6394a90aa358 2024-12-07 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola Ag c142663f-086e-4ab7-a758-9107d7077537 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 984c9793-163c-4b97-b244-9b471966a122 2024-12-05 Warnings Exact identifier application number: M012 BENZEDREX PROPYLHEXEDRINE BF ASCHER AND CO INC 00d8c237-3eee-1d9f-e063-6394a90aeb86 2024-12-05 Warnings Exact identifier application number: M012 Cold Multi Symptom Daytime Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE Chain Drug Marketing Association d5cbb5b0-564c-429e-b680-fa683e796393 2024-12-05 Warnings Exact identifier application number: M012 Cold Relief Multi-Symptom ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCare de8a623f-7b10-4d56-a74b-3737e7716ffe 2024-12-05 Warnings Exact identifier application number: M012 Cold Max Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 9773958b-c5e5-4da7-a8e9-6b6c223a2b30 2024-12-05 Warnings Exact identifier application number: M012 Cold Plus Head Congestion Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 399e0e51-c2a7-451c-b74d-d3db140cef69 2024-12-05 Warnings Exact identifier application number: M012 Head Congestion Plus Mucus PE ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE United Natural Foods, Inc. dba UNFI 09531edc-8dbd-451f-ae02-f922e9e8c248 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 71ca8af7-172d-40da-be1e-ff3ab5568e74 2024-12-05 Warnings Exact identifier application number: M012 SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola Ag b790a91c-33be-4bc3-bdeb-eae6f366f085 2024-12-05 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola Ag ea42e516-2ef8-41c9-ae4e-571f0147bc6b 2024-12-05 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola Ag 8b2d5c0f-509e-447d-b071-d73c4785f120 2024-12-05 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola Ag 8ae0e21a-44a0-4a2c-9880-54eeeaea07ea 2024-12-05 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 6d82469b-d51c-4824-9830-6c1874ad4fe4 2024-12-05 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola Ag e8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce5 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag a535717d-ba55-45e9-9fc3-711b5d7dbf57 2024-12-05 Warnings Exact identifier application number: M012 THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL Ricola Ag 4330ee8d-0b37-4a93-886b-5fc6e6598da7 2024-12-05 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 69729-782-10 69729078210 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69729-782-10) 2019-02-18 0000-00-00 No No Current