Home NDC 53345-034-01 Maximum Strength-Cough and Chest Congestion DM
Product NDC 53345-034
Requested package NDC 53345-034-01
11-digit product format 533450034
Labeler code 53345
Product ID 53345-034_27c8006d-0566-29d6-e063-6394a90a7054
Type HUMAN OTC DRUG
Nonproprietary name Maximum Strength-Cough and Chest Congestion DM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-06-30
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10; 200 mg/1; mg/1
Pharmacologic classes 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]
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 Maximum Strength-Cough and Chest Congestion DM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 mg/1
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 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111663 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 53345-034-01 Maximum Strength-Cough and Chest Congestion DM 4000 in 1 BAG CAPSULE, LIQUID FILLED 4000 3 53345-034-01 Maximum Strength-Cough and Chest Congestion DM 1 in 1 BOX CAPSULE, LIQUID FILLED 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53345-034 MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] 3 Current NDC, Legacy NDC, 2 package rows 20241127_d1830989-fe82-4f08-8618-78979fcef568.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 53345-034-01 53345003401 1 BAG in 1 BOX (53345-034-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2015-06-30 0000-00-00 No No Current