FDA.reportPublic FDA data

tussin dm max daytime nighttime

Product NDC
69842-929
11-digit product format
698420929
Labeler code
69842
Product ID
69842-929_453660bf-e2ab-418a-913a-b9919b7d9137
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hbr, doxylamine succinate, guaifesesin
Dosage form
KIT
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-20
NDC exclude flag
No
Listing certified through
2027-12-31
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
tussin dm max daytime nighttime
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020138Internal RxNorm lookup
1115329Internal RxNorm lookup
2056073Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6feaf29e-de06-4c94-912c-a76ea2cbd8c1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-699-26tussin dm max daytime nighttime1 in 1 CARTONSOLUTION30 mg in 20mL4
69842-699-26tussin dm max daytime nighttime118 mL in 1 BOTTLESOLUTION118 mL12.5 mg in 20mL4
69842-819-26tussin dm max daytime nighttime118 mL in 1 BOTTLESOLUTION118 mL20 mg in 20mL4
69842-819-26tussin dm max daytime nighttime1 in 1 CARTONSOLUTION400 mg in 20mL4
69842-929-12tussin dm max daytime nighttime1 in 1 CARTONKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-929TUSSIN DM MAX DAYTIME NIGHTTIME (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN) KIT [CVS PHARMACY]4Current NDC, Legacy NDC, 5 package rows20241218_6feaf29e-de06-4c94-912c-a76ea2cbd8c1.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 97 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GILTUSS DIABETIC DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corpbd367ce1-996b-45bc-865e-b6aafe0ea7b02025-10-09WarningsExact identifier
application number: M012
Giltuss DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corp1a4fe686-3085-4543-bd6c-f20580b1df502025-10-09WarningsExact identifier
application number: M012
Giltuss D Allergy and CongestionCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2ec-df65-e053-2a91aa0a42fb2025-10-09WarningsExact identifier
application number: M012
GilphexGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp.e7c8fb97-02cf-4df6-b477-9ff69d6b675d2025-10-09WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationd9f26677-ddef-4098-b564-9aa5734e088b2025-10-09WarningsExact identifier
application number: M012
Kalaya Breathe Easy Vaporizing RubVAPORIZING RUBAvaria Health & Beauty Corp7adf96b1-03af-a87b-e053-2a91aa0a45852025-10-08WarningsExact identifier
application number: M012
Equate RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalmart Inc01e1f418-c232-e89e-e063-6294a90abd352025-10-08WarningsExact identifier
application number: M012
EquateOXYMETAZOLINE HCLWalmart Inc020942b1-59d4-a19d-e063-6394a90a5d872025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Assorted Flavors 80ctMENTHOLDollar General425d2e63-f5bc-45fb-b330-967ae64cfddb2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 200ctMENTHOLDollar General Corporationa17aece2-abd8-452a-9da8-2e303845900b2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 30ctMENTHOLDollar General Corporationb96268da-d6f2-41e4-ba04-ce419376f6262025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 30ctMENTHOLDollar General Corporation51ccf39a-ae9b-4e6a-856c-002c296f5d072025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 200ctMENTHOLDollar General Corporation8f8a9474-f388-4ede-85f2-86222b15ee582025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 200ctMENTHOLDollar General Corporationf85f1a15-db7f-4bb5-9313-24702660054e2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 30ctMENTHOLDollar General Corporation61a23ce6-5157-4076-afa7-6a79c62fe9e02025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 30ctMENTHOLDollar General Corporationd5fb7d9e-b0f6-4424-bf67-9e72b50366b12025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 160ctMENTHOLDollar General Corporation9f9916f5-83ea-4f36-b8c2-c6fe1f77884b2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 80ctMENTHOLDollar General Corporationa23ec89a-de7e-4013-b85b-1593e18dc28e2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 160ctMENTHOLDollar General Corporation1833d3bf-6f01-4122-9f4d-4d8b2423fcbb2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 30ctMENTHOLDollar General Corporationfbe92e39-6470-4634-b976-e316baa2c9952025-10-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2056073{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } PackGPCK6feaf29e-de06-4c94-912c-a76ea2cbd8c14
20560731 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution) PackPSN6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSN6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCD6feaf29e-de06-4c94-912c-a76ea2cbd8c14
20560731 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution) PackSY6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSY6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSY6feaf29e-de06-4c94-912c-a76ea2cbd8c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-699-26698420699261 in 1 CARTONHistorical
69842-819-2669842081926118 mL in 1 BOTTLE118 mlHistorical
69842-929-12698420929121 KIT in 1 CARTON (69842-929-12) * 1 BOTTLE in 1 CARTON (69842-699-26) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (69842-819-26) / 118 mL in 1 BOTTLE1 kit2018-07-200000-00-00NoNoCurrent