good sense tussin dm

Product NDC
68788-8300
Requested package NDC
68788-8300-1
11-digit product format
687888300
Labeler code
68788
Product ID
68788-8300_9e8df732-dbdb-4d8b-b999-80d910527308
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
341
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 mg/20mL; mg/20mL
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

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-830068788-8300-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…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
good sense tussin dm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN200 mg/20mL

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
1790650Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
15c8e177-a381-43b2-aed8-d917c7c4372eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8300-1good sense tussin dm118 mL in 1 BOTTLESOLUTION1183
68788-8300-1good sense tussin dm1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8300-1ML - Milliliter68788-8300afb3c041-10f1-411c-98bf-a6a992a8267a12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8300GOOD SENSE TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20250115_15c8e177-a381-43b2-aed8-d917c7c4372e.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPreferred Pharmaceuticals Inc.15c8e177-a381-43b2-aed8-d917c7c4372e2025-01-13WarningsExact identifier
ndc (package): 68788-8300-1
ndc (product): 68788-8300
ndc11 (package): 68788830001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSN15c8e177-a381-43b2-aed8-d917c7c4372e3
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCD15c8e177-a381-43b2-aed8-d917c7c4372e3
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSY15c8e177-a381-43b2-aed8-d917c7c4372e3
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSY15c8e177-a381-43b2-aed8-d917c7c4372e3
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSY15c8e177-a381-43b2-aed8-d917c7c4372e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8300-1687888300011 BOTTLE in 1 CARTON (68788-8300-1) / 118 mL in 1 BOTTLE1 bottle2022-11-300000-00-00NoNoCurrent