FDA.reportPublic FDA data

Night Time Cold and Flu

Product NDC
69256-344
11-digit product format
692560344
Labeler code
69256
Product ID
69256-344_41342da1-b4c9-4814-9d59-2a2a99db2dbb
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
Harris Teeter, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-30
Marketing end
2026-12-28
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
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
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
Night Time Cold and Flu
Brand name suffix
original

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
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
1043400Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cfaf4b3d-fab4-424d-adbe-aaedca58912dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69256-344-12Night Time Cold and Fluoriginal355 mL in 1 BOTTLE, PLASTICLIQUID3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69256-344NIGHT TIME COLD AND FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [HARRIS TEETER, LLC]2Current NDC, Legacy NDC, 1 package rows20231011_cfaf4b3d-fab4-424d-adbe-aaedca58912d.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 29 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLL.N.K. International, Inc.db264d2f-bf81-4da2-8595-2bfa1e4ba2f12026-05-18WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c2026-05-15WarningsExact identifier
application number: M012
good neighbor pharmacy cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergenda91e6b6-32ff-44fd-afce-33ea9549554b2026-05-15WarningsExact identifier
application number: M012
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLC847cdee8-410f-4ff3-9245-976ed6f4c7762026-05-15WarningsExact identifier
application number: M012
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLCd3b2f300-d919-44cd-ab71-b74b5bdfd9772026-05-15WarningsExact identifier
application number: M012
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVERACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDSMEDWISE LIFESCIENCES INC.51d52ce4-98c4-2b9b-e063-6294a90ade442026-05-15WarningsExact identifier
application number: M012
Curewell Tussin DMDEXTROMETHORPHAN, GUAIFENESINRMT HEALTH LLC4fe9ad93-cdc4-b4df-e063-6294a90a90ae2026-05-15WarningsExact identifier
application number: M012
CounterAct Cough Drops Orchard CherryMENTHOLMelaleuca, Inc.6049842c-d763-4a91-a225-976ed74e16932026-05-15WarningsExact identifier
application number: M012
CounterAct Cough Drops Honey LemonMENTHOLMelaleuca, Inc.84ac3489-9d64-401f-ab78-715af4de54402026-05-15WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.51e03b5b-b05a-07c1-e063-6394a90ab2012026-05-15WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-Drowsy/DaytimeACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCLRite Aid Corporation38d73a1e-ac78-4f67-9291-bb48ab80306e2026-05-15WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRWALMART INC.071615ba-f50a-4d2a-a358-43140bccce722026-05-14WarningsExact identifier
application number: M012
Severe Cold and Flu Nighttime DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Incd4bcfabb-a054-4f53-8dc9-d361a03558b82026-05-14WarningsExact identifier
application number: M012
Cough and Chest Congestion DM AdultDEXTROMETHORPHAN HBR, GUAIFENESINCVS Pharmacy4444c05a-eba6-4633-b86f-34f455699fa92026-05-14WarningsExact identifier
application number: M012
Topcare Day Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTopco Associates LLCa88e5b8e-e6dd-4a1c-9628-5861d3205bdb2026-05-14WarningsExact identifier
application number: M012
equate daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc69b24c67-cf4b-46d7-a44b-d1917cc876b12026-05-14WarningsExact identifier
application number: M012
GILTUSS DIABETIC EXGILTUSS DIABETIC EXGil Pharmaceutical Corpab7915e7-323a-4fe1-887a-a3bd3f0aac982026-05-13WarningsExact identifier
application number: M012
Giltuss EX Maximum Strength ExpectorantGILTUSS EX MAXIMUM STRENGTH EXPECTORANTGil Pharmaceutical Corp950db1ca-6936-47f8-a112-e3594d4c922c2026-05-13WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGILTUSS EX EXPECTORANTGil Pharmaceutical Corp3b363fb9-c4d3-446f-927c-f705ffc715b52026-05-13WarningsExact identifier
application number: M012
Giltuss HBP EX ExpectorantGILTUSS HBP EX EXPECTORANTGil Pharmaceutical Corp31bd6356-27cf-4188-8fd5-9cd9392021ca2026-05-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNcfaf4b3d-fab4-424d-adbe-aaedca58912d3
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDcfaf4b3d-fab4-424d-adbe-aaedca58912d3
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYcfaf4b3d-fab4-424d-adbe-aaedca58912d3
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYcfaf4b3d-fab4-424d-adbe-aaedca58912d3
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYcfaf4b3d-fab4-424d-adbe-aaedca58912d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69256-344-1269256034412355 mL in 1 BOTTLE, PLASTIC (69256-344-12) 355 ml2021-04-302026-12-28NoNoCurrent