nighttime cough dm

Product NDC
79481-6101
11-digit product format
794816101
Labeler code
79481
Product ID
79481-6101_a53de8b7-c57f-406b-8453-51a2629b87c4
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Meijer, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-22
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
30; 12.5 mg/20mL; mg/20mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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

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
nighttime cough dm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/20mL
DOXYLAMINE SUCCINATE12.5 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
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5a45b4c2-6a15-40b4-9ac6-d1554244ec42Available on FDA.report

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 137 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Oxymetazoline Sinus SevereOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)13237d31-c60a-49f8-9b96-4414cf766a082024-11-21WarningsExact identifier
application number: M012
DayTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.5b55d1df-275b-40d8-bde3-fc43313b7eb32024-11-20WarningsExact identifier
application number: M012
Halls Green AppleMENTHOLMondelez Global LLC1bb8dcb2-c3a8-a64e-e063-6294a90ae4a22024-11-20WarningsExact identifier
application number: M012
Halls BlueberryMENTHOLMondelez Global LLC275a6935-ea44-486e-e063-6394a90ae19a2024-11-20WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYWalgreens Company234bd567-4e3c-419f-a000-fdfc28cafc8b2024-11-20WarningsExact identifier
application number: M012
NICE Assorted Cough DropsMENTHOLLeosons Overseas Corp96db0f37-41cc-1ebd-e053-2a95a90a32152024-11-19WarningsExact identifier
application number: M012
Nice Cherry Cough DropsMENTHOLLeosons Overseas Corp98e52604-6e41-6408-e053-2995a90a6bc82024-11-19WarningsExact identifier
application number: M012
NICE Citrus Cough DropsMENTHOLLeosons Overseas Corp96d9527d-9bf9-ce82-e053-2995a90aff0c2024-11-19WarningsExact identifier
application number: M012
NICE Menthol Cough DropsMENTHOLLeosons Overseas Corp96d77897-475c-482c-e053-2995a90a2da42024-11-19WarningsExact identifier
application number: M012
NICE Honey Lemon Cough DropsMENTHOLLeosons Overseas Corp96da2c9d-2d0d-6252-e053-2995a90ac3382024-11-19WarningsExact identifier
application number: M012
SanaTos BoostDEXTROMETHORPHAN HBRPharmadel LLCae6a424f-f3f0-3f6c-e053-2995a90a972d2024-11-18WarningsExact identifier
application number: M012
SanaTos Turbo Max StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLPharmadel LLCd56a071c-a747-5397-e053-2995a90aad8b2024-11-18WarningsExact identifier
application number: M012
cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E B404ef5f4-7b7b-4c08-b159-9175a91be1322024-11-17WarningsExact identifier
application number: M012
equaline childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa24021a0-ef68-4bce-ba53-d262d1025cc02024-11-17WarningsExact identifier
application number: M012
Cold and Cough DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Inc4d5f93c1-7752-4948-ba58-c4385cfc24c82024-11-17WarningsExact identifier
application number: M012
Good Sense Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company8a87104f-94a4-4585-afd5-d610eea32e392024-11-17WarningsExact identifier
application number: M012
equate childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Incc91e94f4-4c51-4fe7-ad2e-0b9dc58b51e42024-11-17WarningsExact identifier
application number: M012
foster and thrive childrens allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEStrategic Sourcing Services LLC1eac715b-351c-4b47-8d1d-6e921813c1a42024-11-15WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC298d2796-5ae5-4346-b6d2-2ced2dd29dc32024-11-15WarningsExact identifier
application number: M012
dg health day time severe cold and flu relief night time severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEDolgencorp, LLCf721b393-9ad5-4fc6-a2c5-bd89e58caf162024-11-15WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-6101-1794816101011 BOTTLE in 1 CARTON (79481-6101-1) / 118 mL in 1 BOTTLE (79481-6101-4) 1 bottle2026-07-22NoNoCurrent