FDA.reportPublic FDA data

berkley and jensen tussin dm

Product NDC
68391-299
11-digit product format
683910299
Labeler code
68391
Product ID
68391-299_0ca69d3c-9854-47d1-9613-1bae9416051d
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
BJWC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-02
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 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

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
berkley and jensen tussin dm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 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
1020138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2de91c9-6af0-4881-8d2d-a69d90c8dfcdAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-299-34berkley and jensen tussin dm1 in 1 CARTONSOLUTION12
68391-299-34berkley and jensen tussin dm237 mL in 1 BOTTLESOLUTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-299BERKLEY AND JENSEN TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [BJWC]2Current NDC, Legacy NDC, 2 package rows20241120_b2de91c9-6af0-4881-8d2d-a69d90c8dfcd.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 22 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLStrategic Sourcing Services LLC067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a62026-06-16WarningsExact identifier
application number: M012
Equate Severe Cold Cough and FluACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.a35531d7-1a96-45cb-922f-61db085cde1f2026-06-16WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company5fe9f313-d6e7-41f5-abfc-e4c72b7089612026-06-15WarningsExact identifier
application number: M012
Pain Relief Sinus CongestionACETAMINOPHEN, PHENYLEPHRINE HCLBetter Living Brands, LLC1d3d6397-0d92-4145-9a70-8bcc45bd03222026-06-15WarningsExact identifier
application number: M012
Goodmeds Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f112026-06-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationd5d9334d-3db6-4f45-ab84-3e1ec5a752c62026-06-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLGeiss, Destin & Dunn Inc.fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b2026-06-15WarningsExact identifier
application number: M012
equate daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWal-Mart Stores Inc983a4783-d826-41b6-8087-ca66bcd5b6ca2026-06-12WarningsExact identifier
application number: M012
Equate Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc4173ecde-a2d7-4836-a6e9-fef2270d1b4e2026-06-12WarningsExact identifier
application number: M012
PAIN RELIEVER PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBest Choice (Valu Merchandisers Company)cf370a59-42d5-42fe-882f-09885c55f5702026-06-11WarningsExact identifier
application number: M012
Sudafed Sinus Congestion Plus Cold Severe DayACETAMINOPHEN, PSEUDOEPHEDRINEKenvue Brands LLC537e1a0d-820d-c3f7-e063-6294a90a56ea2026-06-10WarningsExact identifier
application number: M012
Sudafed Sinus Congestion plus Cold Severe Day and NightACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINEKenvue Brands LLC5382dcad-0337-4440-e063-6394a90a706e2026-06-10WarningsExact identifier
application number: M012
good neighbor pharmacy nasalOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.21cfa71c-7a8f-4100-a42e-9190260653d12026-06-09WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCLWALGREENS47f1d92f-cb4b-1635-e063-6294a90a2c712026-06-09WarningsExact identifier
application number: M012
HALLS HoneyMENTHOLMondelez Global LLC837f5ded-8efb-402b-a1bc-b5c1427556602026-06-09WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution Inc932b11b1-f4a0-417a-bfa1-05261a1721552026-06-08WarningsExact identifier
application number: M012
NO DRIP NASAL MISTOXYMETAZOLINE HYDROCHLORIDEKroger Company957efbcf-b6d3-4793-bb6e-27e99c9be9052026-06-08WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED493caecb-e687-49ea-b7a1-2a5b9376896d2026-06-08WarningsExact identifier
application number: M012
Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY4ad10fd7-c088-4356-9d34-a95cfe3a41332026-06-08WarningsExact identifier
application number: M012
Theraflu Severe Congestion Relief Nasal MistOXYMETAZOLINE HCLHaleon US Holdings LLC4ec42064-7390-4137-a93e-57343c3c76a72026-06-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-299-34683910299341 BOTTLE in 1 CARTON (68391-299-34) / 237 mL in 1 BOTTLE1 bottle2022-01-020000-00-00NoNoCurrent