FDA.reportPublic FDA data

Night Time Cold and Flu

Product NDC
49580-0343
11-digit product format
495800343
Labeler code
49580
Product ID
49580-0343_6b8c5604-2fc0-4acb-a71e-0a9ae331fd4e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
P & L Development, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-31
Marketing end
2026-12-31
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

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 · 5 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage49580-0343-8
excluded packagepackage49580-0343-4
excluded packagepackage49580-0343-6
excluded packagepackage49580-0343-2

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
ReadyInCase

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
e7dd763b-3005-4723-933b-171eb772afeeAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
49580-0343-22023-05-24Drug Facts
49580-0343-22023-05-24Drug Facts
49580-0343-42023-05-24Drug Facts
49580-0343-42023-05-24Drug Facts
49580-0343-62023-05-24Drug Facts
49580-0343-62023-05-24Drug Facts
49580-0343-82023-05-24Drug Facts
49580-0343-82023-05-24Drug Facts
49580-0343-22023-01-30Drug Facts
49580-0343-22023-01-30Drug Facts
49580-0343-42023-01-30Drug Facts
49580-0343-42023-01-30Drug Facts
49580-0343-62023-01-30Drug Facts
49580-0343-62023-01-30Drug Facts
49580-0343-82023-01-30Drug Facts
49580-0343-82023-01-30Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0343-2Night Time Cold and FluReadyInCase355 mL in 1 BOTTLE, PLASTICLIQUID35513
49580-0343-4Night Time Cold and FluReadyInCase118 mL in 1 BOTTLE, PLASTICLIQUID11813
49580-0343-6Night Time Cold and FluReadyInCase177 mL in 1 BOTTLE, PLASTICLIQUID17713
49580-0343-8Night Time Cold and FluReadyInCase237 mL in 1 BOTTLE, PLASTICLIQUID23713

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLNIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KNIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0343NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [P & L DEVELOPMENT, LLC]11Current NDC, Legacy NDC, 4 package rows20241211_e7dd763b-3005-4723-933b-171eb772afee.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 89 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
G-Supress DXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS5dd44337-f3aa-4e73-a206-4a29850a2f7c2025-11-12WarningsExact identifier
application number: M012
Allergy Relief CompleteDIPHENHYDRAMINE HCLWinCo Foods, LLC15b3de6c-7ccc-408b-8789-d0e2f21a88352025-11-12WarningsExact identifier
application number: M012
PRESGEN PEDIATRICGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDEKRAMER NOVIS12fb91e5-6059-4b3a-a2de-762aa51a25b72025-11-12WarningsExact identifier
application number: M012
SorbugenDEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATEKramer Novisa8f2a2d7-0360-45a8-9635-c852f4a7d7ba2025-11-12WarningsExact identifier
application number: M012
DESGEN DMDEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCLKramer Novis6ab47174-e1fd-47ce-8788-06b7cdad52182025-11-12WarningsExact identifier
application number: M012
PresgenGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novisedad7a86-0d27-4a98-85b2-4b6725904f282025-11-12WarningsExact identifier
application number: M012
TUSICOFDEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINEKramer Novise966b75c-4bb4-4216-8247-baada8f5d7592025-11-12WarningsExact identifier
application number: M012
Fast Acting Mucus Relief Maximum Strength Severe Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)52327ed0-ea49-4d1c-b928-20ab381be9f22025-11-11WarningsExact identifier
application number: M012
TOPCO Childrens Cough ReliefDEXTROMETHORPHAN HBR AND GUAIFENESINTopco Associates, LLCee0f5627-5104-4990-88ee-2fb46965bc1e2025-11-11WarningsExact identifier
application number: M012
TOPCARE Childrens Cold and Cough and Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDETopco Associates, LLC8931d4ca-c599-49be-87e1-8c0598f38b772025-11-11WarningsExact identifier
application number: M012
TOPCARE Multi Symptom Flu Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLC01c517e5-d693-4926-9eb5-4b894a2f69172025-11-11WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b4a2a-d6bf-ec25-e063-6294a90a3f062025-11-11WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435e6387-1ee0-c20f-e063-6294a90adac52025-11-11WarningsExact identifier
application number: M012
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b2025-11-10WarningsExact identifier
application number: M012
TOPCARE Childrens Allergy ChewsDIPHENHYDRAMINE HCLTopco Associates, LLCb5e15dd1-6e99-411c-9183-8a4265eae4042025-11-08WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corp103de130-ef12-4c58-bbcf-234b3f3b2cbf2025-11-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry 30ctMENTHOLDollar General Corporation2b3fbab9-92b5-42a7-b27b-ff46350ce0552025-11-07WarningsExact identifier
application number: M012
Robitussin Day and Night Maximum Strength Cough DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb43d8fbd-1977-4465-aa64-79e7b7f54e092025-11-07WarningsExact identifier
application number: M012
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp093649a4-f968-49bd-83af-bb7e0f448ecf2025-11-07WarningsExact identifier
application number: M012
TARGET Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTARGET CORPORATIONbfc91c71-0506-4e94-8bfe-dc9e4bf959da2025-11-07WarningsExact 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 SolutionPSNe7dd763b-3005-4723-933b-171eb772afee13
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDe7dd763b-3005-4723-933b-171eb772afee13
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYe7dd763b-3005-4723-933b-171eb772afee13
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYe7dd763b-3005-4723-933b-171eb772afee13
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYe7dd763b-3005-4723-933b-171eb772afee13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49580-0343-249580034302355 mL in 1 BOTTLE, PLASTIC (49580-0343-2) 355 ml2014-10-312026-12-31NoNoCurrent
49580-0343-449580034304118 mL in 1 BOTTLE, PLASTIC (49580-0343-4) 118 ml2014-10-312026-12-31NoNoCurrent
49580-0343-649580034306177 mL in 1 BOTTLE, PLASTIC (49580-0343-6) 177 ml2014-10-312026-12-31NoNoCurrent
49580-0343-849580034308237 mL in 1 BOTTLE, PLASTIC (49580-0343-8) 237 ml2014-10-312026-12-31NoNoCurrent