FDA.reportPublic FDA data

all nite

Product NDC
0904-6465
11-digit product format
009046465
Labeler code
0904
Product ID
0904-6465_9bfd7bea-ca99-41ae-a92f-4c91ac3327f3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-11-19
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
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
all nite
Listing expiration
2027-12-31

Active Ingredients#

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

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6465-09all nite237 mL in 1 BOTTLESOLUTION2375

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6465-09ML - Milliliter0904-64650311bb96-dabb-460d-b725-f5d4a124830112016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6465ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 1 package rows20241025_945a4068-3630-4f1d-b794-d2f1603af285.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 51 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEBryant Ranch Prepack09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b2026-02-17WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEHyVee Ince8a48a00-3533-4c4d-94e1-8a6c6b35a7922026-02-17WarningsExact identifier
application number: M012
cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Inc1f3efcdd-4976-4aef-a7c6-a5f88d13cb782026-02-17WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Incd5bbb5e1-ff09-4563-b2c6-149ab30e06ad2026-02-17WarningsExact identifier
application number: M012
Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRChain Drug Marketing Association, Inc.3c8f34ad-589a-4872-939c-44ad5e0e47fe2026-02-17WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLValu Merchandisers Companyb6144732-99da-4be2-88e0-75f31b323d382026-02-16Warnings, Adverse reactionsExact identifier
application number: M012
topcare day time cold and flu relief multi symptom reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates LLC6d08ca2d-6ae4-443f-9920-34b7fb46f2b42026-02-16WarningsExact identifier
application number: M012
Revasol Acetaminophen SuspensionACETAMINOPHENRnv LLC4ab6bb54-7c28-0c6b-e063-6394a90ac4a62026-02-13WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTopco Associates LLC62eed0e8-ba5f-45c2-a543-68b50bcf4b0c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M012
Revasol Acetaminophen Suspension Dye FreeACETAMINOPHENRnv LLC4abc07b3-6a27-260f-e063-6394a90a28d62026-02-13WarningsExact identifier
application number: M012
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMajor Pharmaceuticals5e19220d-9cf3-4732-b9aa-c09db5d69ce62026-02-13WarningsExact identifier
application number: M012
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC686b9456-f16d-4b99-ae58-f607448bed8b2026-02-13WarningsExact identifier
application number: M012
nasalPHENYLEPHRINE HYDROCHLORIDEKroger Company1c3dc4e6-452b-4c84-b53c-426cf9ae8f032026-02-12WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFIaf42d3f7-661e-4322-aefe-2b7f9f1010d62026-02-12WarningsExact identifier
application number: M012
Childrens Giltuss DCHILDRENS GILTUSS DGil Pharmaceutical Corpcfc2493b-e99e-4b55-98a9-053f95d498442026-02-12WarningsExact identifier
application number: M012
Giltuss DGILTUSS DGil Pharmaceutical Corp298f5457-a7df-474d-9854-68918ee3d3302026-02-12WarningsExact identifier
application number: M012
VaporizingCAMPHORWalgreen Co.ef4f95c8-7650-4096-9369-ea8393781bee2026-02-12Warnings, Adverse reactionsExact identifier
application number: M012
Oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDEProdose, Inc.3dce34f0-9f6d-8151-e063-6394a90a1d382026-02-11WarningsExact identifier
application number: M012
SIGNATURE CARE Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESAFEWAY831da7b6-25c7-4601-b7f1-1800a238b0162026-02-11WarningsExact identifier
application number: M012
Allergy Plus Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d2cf481-622f-4262-b0bd-c38fe5de67212026-02-11WarningsExact 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 SolutionPSN945a4068-3630-4f1d-b794-d2f1603af2855
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD945a4068-3630-4f1d-b794-d2f1603af2855
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY945a4068-3630-4f1d-b794-d2f1603af2855
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY945a4068-3630-4f1d-b794-d2f1603af2855
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY945a4068-3630-4f1d-b794-d2f1603af2855

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6465-0900904646509237 mL in 1 BOTTLE (0904-6465-09) 237 ml2012-11-190000-00-00NoNoCurrent