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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief Diphenhydramine HCl 25mg SoftGelDIPHENHYDRAMINE HYDROCHLORIDENUVICARE LLCbb728ceb-8eb0-4192-a8b0-742756819a052025-06-26WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDETIME CAP LABORATORIES, INC7aee34b5-1583-4a8a-8ffb-b17ef2722ac12025-06-25WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDEWALGREENSc0270298-e7c5-e500-e053-2995a90aed232025-06-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.24ff91f2-02db-56a2-e063-6394a90a31c92025-06-25WarningsExact identifier
application number: M012
Cough and Chest Congestion Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.e920b700-30d3-3266-e053-2a95a90a06392025-06-24WarningsExact identifier
application number: M012
good sense childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEL. Perrigo Company2ffe0fbc-236d-417b-bbfd-5b9294f3c90a2025-06-23WarningsExact identifier
application number: M012
Exchange Select Cough Drop Black Cherry Sugar FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.38034ad2-5eab-9caf-e063-6294a90abb8f2025-06-20WarningsExact identifier
application number: M012
Herbal Cough DropsHERBAL MENTHOLMeijer, Inc.380364be-4e52-fa52-e063-6394a90a713c2025-06-20WarningsExact identifier
application number: M012
DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c55543-e05e-2f7c-e063-6394a90a45342025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.38049d29-f47e-9478-e063-6294a90aa2a42025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Menthol Sugar FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3804a271-9a11-848d-e063-6394a90af87d2025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Menthol Sugar FreeMENTHOLArmy & Air Force Exchange Service3805ef07-247d-0df7-e063-6394a90ac45b2025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drop Black Cherry Sugar FreeMENTHOLArmy & Air Force Exchange Service3805f8f5-562f-0ba8-e063-6394a90ac9d92025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-FreeMENTHOLArmy & Air Force Exchange Service3805f90e-bd89-128d-e063-6394a90afa012025-06-20WarningsExact identifier
application number: M012
TARGET Multi Symptom Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTARGET CORPORATIONaebe3c15-53ef-46ea-af39-8c9b8114595f2025-06-20WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTCbe95332d-a2e0-42e8-bfb3-8850d74990ff2025-06-19WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTC37e939c6-064b-3548-e063-6294a90a337d2025-06-19WarningsExact identifier
application number: M012
Capron DMDEXTROMETHORPHAN HBR AND PYRILAMINE MALEATECapital Pharmaceutical, LLCcf778c5f-475e-4a86-a87c-2be1e665f5a52025-06-18WarningsExact identifier
application number: M012
Cough OutGUAIFENESINEfficient Laboratories Inc.fe4c3921-8d30-4cd6-ba90-9211b362a38a2025-06-18WarningsExact identifier
application number: M012
Guaifenesin STRAWBERRY-BANANA FLAVORGUAIFENESINInnovida Pharmaeutique Corporation1006906e-d6d7-4f49-92bf-3cb2d2cdbb162025-06-18WarningsExact 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