FDA.reportPublic FDA data

Tussin DM

Product NDC
53943-503
11-digit product format
539430503
Labeler code
53943
Product ID
53943-503_62dd7291-4bbf-4c2f-8cd0-7b5cd174768e
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
Discount Drug Mart
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-19
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 100 mg/5mL; mg/5mL
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
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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53943-503-26IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53943-503-26IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53943-503-26EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
Tussin DM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996520Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd31f86b-f59e-459a-8e5f-176828706a4aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-503-262020-12-31C16284748780-19d75b9cf-f5b1-f424-e053-dadaa90a57cedd31f86b-f59e-459a-8e5f-176828706a4a
53943-503-262020-01-31C16284748780-19d75b9cf-f5b1-f424-e053-dadaa90a57cedd31f86b-f59e-459a-8e5f-176828706a4a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-503-26Tussin DM237 mL in 1 PACKAGELIQUID2376

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-503TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]5Current NDC, Legacy NDC, 1 package rows20241222_dd31f86b-f59e-459a-8e5f-176828706a4a.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 108 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.377248b6-d64d-8dff-e063-6394a90a43f62025-07-31WarningsExact identifier
application number: M012
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.3771f778-7ac9-7108-e063-6394a90a11052025-07-31WarningsExact identifier
application number: M012
tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINCVS Pharmacy087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca2025-07-31WarningsExact identifier
application number: M012
Equate NasalOXYMETAZOLINE HCLWal-Mart Stores Incc38a2783-aed9-466d-8976-59d03a792c042025-07-30WarningsExact identifier
application number: M012
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3b15d2ea-f784-275d-e063-6394a90a800c2025-07-29WarningsExact identifier
application number: M012
Respiratory ReliefGUAIFENESINSchwabe North America, Incf683041a-4ff9-42a5-9047-a9a3140a87582025-07-29WarningsExact identifier
application number: M012
Childrens Robitussin Honey Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCb87f700e-3414-463c-80d4-c3dbca89a4882025-07-29WarningsExact identifier
application number: M012
Tussin DMTUSSIN DMAllegiant Health7a2f8d48-3123-4c37-b238-bd7cc4242bb72025-07-23WarningsExact identifier
application number: M012
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Inc5fb2438b-8f2d-4af2-9981-42d278d268002025-07-23WarningsExact identifier
application number: M012
DR. SANA COUGH AND CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Incbaca0580-4c30-4b94-89fa-a7cf06d4ff252025-07-22WarningsExact identifier
application number: M012
Defensol DACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCIMenper Distributors, Inc.f466c660-69eb-4581-81ff-1499fa421d8b2025-07-22WarningsExact identifier
application number: M012
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
application number: M012
BroncofinDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMenper Distributors, Inc.fdf67382-1692-485b-92f1-2cbb8be4fb702025-07-22WarningsExact identifier
application number: M012
Defensol Adult SyrupGUAIFENESIN, DEXTROMETHORPHAN HBRMenper Distributors, Inc.62acff69-8c40-4a0e-8d56-be2cc14e3d452025-07-22WarningsExact identifier
application number: M012
Cosedal DropsDEXTROMETHORPHAN HBR, GUAIFENESINMenper Distributors, Inc.1241d249-ea3b-4d2b-87ed-835d6a2d286a2025-07-22WarningsExact identifier
application number: M012
Berro y Cebolla DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMenper Distributors, Inc.20107bd9-6d84-4ab5-a0d9-966f1f11d9192025-07-22WarningsExact identifier
application number: M012
Defensol-itoDEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINEMenper Distributors, Inca7c7a60d-d49f-4239-92f7-714eac7eb0c52025-07-22WarningsExact identifier
application number: M012
Bisolvine ChildrenGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.896a5443-e3d2-4af7-9e27-f1c1899ce0382025-07-22WarningsExact identifier
application number: M012
Bisolvine Aloe-MielDEXTROMETHORPHAN, GUAIFENESINMENPER DISTRIBUTORS INC.34801c79-ce88-492f-808e-b639e86016072025-07-22WarningsExact identifier
application number: M012
Viva Porru Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILMenper Distributors, Inc.0dfadfe3-9e40-0eee-e063-6294a90a00c32025-07-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNdd31f86b-f59e-459a-8e5f-176828706a4a6
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDdd31f86b-f59e-459a-8e5f-176828706a4a6
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYdd31f86b-f59e-459a-8e5f-176828706a4a6
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYdd31f86b-f59e-459a-8e5f-176828706a4a6
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYdd31f86b-f59e-459a-8e5f-176828706a4a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-503-2653943050326237 mL in 1 PACKAGE (53943-503-26) 237 ml2014-11-190000-00-00NoNoCurrent