FDA.reportPublic FDA data

DRX CHOICE

Product NDC
68163-062
11-digit product format
681630062
Labeler code
68163
Product ID
68163-062_f466fc0e-3384-4884-832e-99bf1fdcf899
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Raritan Pharmaceuticals Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
325; 15; 6.25 mg/1; mg/1; mg/1
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
DRX CHOICE
Brand name suffix
NIGHTTIME COLD and FLU RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
DOXYLAMINE SUCCINATE6.25 mg/1

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
1094549Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f466fc0e-3384-4884-832e-99bf1fdcf899Available 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
68163-062-10DRX CHOICENIGHTTIME COLD and FLU RELIEF5 in 1 CARTONCAPSULE, LIQUID FILLED51
68163-062-10DRX CHOICENIGHTTIME COLD and FLU RELIEF2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED21

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 114 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTINGCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRHaleon US Holdings LLCbecb4025-b63e-f2ea-9d11-d51fdf4e5c132025-06-04WarningsExact identifier
application number: M012
Diphenhydramine HCL STRAWBERRY FLAVORDIPHENHYDRAMINE HCLInnovida Pharmaeutique Corporation7eb709a5-c587-4f1d-bc2d-576d07a3a3bf2025-06-04WarningsExact identifier
application number: M012
Children Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLTARGET CORPORATION69d33f77-06e1-48fa-a516-892fdf11bb1c2025-06-03WarningsExact identifier
application number: M012
oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fd058e2b-5445-e416-e053-6394a90a611b2025-06-03WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.36b1a7e0-c8b9-0890-e063-6394a90ab13a2025-06-03WarningsExact identifier
application number: M012
COLD, FLU and SORE THROAT RELIEFACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MGBETTER LIVING BRANDS, LLC202d60a8-83da-5afc-e063-6394a90ad7792025-05-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLTARGET CORPORATIONf935341f-1e33-d78e-e053-6294a90a348e2025-05-30WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLAARNA USA INC.365bb414-8425-a900-e063-6394a90aa8872025-05-30WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEP & L Development, LLC8559be55-8b00-4353-8e26-b5dff2ada8062025-05-30WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalmart Inc.35da8429-1f83-9e81-e063-6294a90a35152025-05-23WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORP9dfef3dc-dbc8-659a-e053-2995a90a8c3b2025-05-21WarningsExact identifier
application number: M012
Adult TussinGUAIFENESINCamber Consumer Care896d2540-279a-4405-b176-acbff56303e52025-05-20WarningsExact identifier
application number: M012
Nuvicare NightTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATENUVICARE LLC37a88914-6234-4191-86f5-103c396c52af2025-05-20WarningsExact identifier
application number: M012
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLC1ea15426-4f3d-4a97-a590-6bd73bc6cbcd2025-05-19WarningsExact identifier
application number: M012
Quality Choice NasalOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION3833e781-f6ee-4c6d-8756-d8ea2293a1f22025-05-19WarningsExact identifier
application number: M012
Quality Choice Nasal Mist Severe CongestionOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONd45e99e5-ce66-4458-8d23-63a5dc7ae5092025-05-19WarningsExact identifier
application number: M012
Quality Choicel Nasal Mist Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION460f0cc1-6a85-4d79-af87-a94fd151769e2025-05-19WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC812a093f-cf83-4f7a-927a-1b5695be7f902025-05-19WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINSDA Laboratories, Inc.1fd16b06-0c3e-4a30-ae6a-7b1632189c202025-05-16WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLAkron Pharma Inc.79a6b8c7-0e81-4a46-a854-31f4490427092025-05-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNf466fc0e-3384-4884-832e-99bf1fdcf8991
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDf466fc0e-3384-4884-832e-99bf1fdcf8991
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYf466fc0e-3384-4884-832e-99bf1fdcf8991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68163-062-10681630062105 BLISTER PACK in 1 CARTON (68163-062-10) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK5 blister pack2025-12-01NoNoCurrent