FDA.reportPublic FDA data

XL-3 Xtreme

Product NDC
76281-307
11-digit product format
762810307
Labeler code
76281
Product ID
76281-307_95f58511-c4d4-4a9d-b8be-ba0b464f2e59
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
AptaPharma Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-01
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
2026-12-31
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
XL-3 Xtreme
Listing expiration
2026-12-31

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
V9BI9B5YI2Internal UNII lookup
9D2RTI9KYHInternal UNII lookup
362O9ITL9DInternal 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
dff79e0b-edf0-4dd3-a722-fd9beecd6293Available 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
76281-307-25XL-3 Xtreme177 mL in 1 BOTTLELIQUID1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-307XL-3 XTREME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [APTAPHARMA INC.]4Current NDC, Legacy NDC, 1 package rows20231231_dff79e0b-edf0-4dd3-a722-fd9beecd6293.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 24 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allegra Allergy 24 hourFEXOFENADINE HYDROCHLORIDESelect Consumer Group2de81a41-8488-7e39-e063-6294a90a394b2026-06-01WarningsExact identifier
application number: M012
Cough and Runny Nose Childrens PlusACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDETOP CARE (Topco Associates LLC)6f04bd51-093c-4624-aef3-0145ac3873862026-06-01WarningsExact identifier
application number: M012
NasalPHENYLEPHRINE HYDROCHLORIDECVS Pharmacy694a3116-1b75-42cd-bbcf-d19831c2d7962026-06-01WarningsExact identifier
application number: M012
night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH E Bcf31538c-9eee-4c81-80cb-66eecabf0aff2026-06-01WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC155e07b3-0a08-3be8-e063-6394a90a76352026-05-31WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough NighttimeDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC156033ae-b16a-007b-e063-6294a90a74452026-05-31WarningsExact identifier
application number: M012
Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyebf8c82d-a653-4c02-893b-61704901acbb2026-05-29WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLAmerisource Bergen934c7b91-3cba-47f0-8efa-77216f3f15c42026-05-29WarningsExact identifier
application number: M012
Allergy MedicineDIPHENHYDRAMINE HCLCOSTCO WHOLESALE CORPORATIONd9f03e11-d11f-43ee-8ed0-9e07d1058f662026-05-29WarningsExact identifier
application number: M012
Cold Childrens, Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYeaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d2026-05-29WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC3598ac5b-29f9-f002-e063-6294a90a62cb2026-05-28WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC51badd2f-4a43-3dbe-e063-6294a90a4bd12026-05-28WarningsExact identifier
application number: M012
Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.a7ab2140-de09-158f-e053-2a95a90a25a02026-05-28WarningsExact identifier
application number: M012
Kids Multi Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.2d918ec8-3098-1d09-e063-6294a90a9e8f2026-05-28WarningsExact identifier
application number: M012
Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLGenexa Inc.213fe898-dace-9a0f-e063-6394a90afd642026-05-28WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey Lemon FlavorMENTHOLMedical Group Care LLC556628ab-e233-92fe-e063-6394a90a00902026-05-28WarningsExact identifier
application number: M012
Sinus Decongestion PEPHENYLEPHRINE HCLKroger Company68eff734-177e-4999-9126-6b92bb2041072026-05-28WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRARMY AND AIR FORCE EXCHANGE SERVICEff39084f-ab2f-48ed-ac62-837f7fff2b652026-05-28WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group LLC52c5fda0-c358-72e8-e063-6394a90a3f682026-05-27WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo PackDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC16637d54-8049-d3ce-e063-6394a90aafc92026-05-27WarningsExact 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 SolutionPSNdff79e0b-edf0-4dd3-a722-fd9beecd62934
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDdff79e0b-edf0-4dd3-a722-fd9beecd62934
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYdff79e0b-edf0-4dd3-a722-fd9beecd62934
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYdff79e0b-edf0-4dd3-a722-fd9beecd62934
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYdff79e0b-edf0-4dd3-a722-fd9beecd62934

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76281-307-2576281030725177 mL in 1 BOTTLE (76281-307-25) 177 ml2018-09-010000-00-00NoNoCurrent