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
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
XL-3 Xtreme
Listing expiration
2027-12-31

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
362O9ITL9DInternal UNII lookup
V9BI9B5YI2Internal UNII lookup
9D2RTI9KYHInternal 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 149 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen665db127-ee04-46c4-bff0-e0fe9950c3e22024-10-18WarningsExact identifier
application number: M012
Cold Max Day and NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen87a1cc06-9994-4fa9-8c64-e2ffdd33a2f82024-10-18WarningsExact identifier
application number: M012
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen604d7e53-4bfd-4cdd-aed2-b304ae82ce442024-10-18WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HYDROCHLORIDEDISCOUNT DRUG MART4d93a703-c905-4fb3-b772-11c207065d4d2024-10-17WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART62c35320-87b5-46e2-9f6f-cb0882bdb52e2024-10-17WarningsExact identifier
application number: M012
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe3dcf6cf-373c-ea83-e053-2a95a90ae57a2024-10-17WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa7e99dad-5918-6a90-e053-2a95a90a88032024-10-17WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa7e99dad-5916-6a90-e053-2a95a90a88032024-10-17WarningsExact identifier
application number: M012
ALLERGY MULTISYMPTOMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa7e9ab8e-2252-180d-e053-2a95a90a788f2024-10-17WarningsExact identifier
application number: M012
COLD PLUS HEAD CONGESTION SEVEREACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART3430c7e4-e142-407e-bed5-358dd6bd10f72024-10-17WarningsExact identifier
application number: M012
COLD MAXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa1aba467-c91f-4812-b0b9-ff5fdfa298e32024-10-17WarningsExact identifier
application number: M012
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe3dd12f1-dd63-27ae-e053-2995a90aaaeb2024-10-17WarningsExact identifier
application number: M012
COLD and FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe44ac549-3e9b-4271-a2b2-ecb124f798322024-10-17WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTf171a389-8b22-429c-86bc-272156fdc1b72024-10-17WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART6c5b5427-e47a-4eff-928a-c891452facf92024-10-17WarningsExact identifier
application number: M012
COLD AND FLU SEVEREACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTddeb8978-84b6-4a19-b25e-99d1c29e58d92024-10-17WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTb20baef9-6e68-6679-e053-2a95a90a2b632024-10-17WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTb20b71fb-8787-c871-e053-2a95a90a8eb42024-10-17WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTb20bc492-fed3-bf05-e053-2a95a90ad3932024-10-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIa4d6ecb9-ea67-41ed-917b-9bb4d1e505512024-10-17WarningsExact 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