FDA.reportPublic FDA data

basic care nighttime cold and flu

Product NDC
72288-056
11-digit product format
722880056
Labeler code
72288
Product ID
72288-056_1b7bcede-dcd0-4d11-9281-3f8aadd040df
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-28
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
basic care nighttime cold and flu
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
f4497e56-c69d-4ae9-bd81-80bf2ee1b17fAvailable 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
72288-056-00basic care daytime cold and flu nighttime cold and flu8 in 1 CARTONCAPSULE, LIQUID FILLED6.25 mg3
72288-056-00basic care daytime cold and flu nighttime cold and flu2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED166.25 mg3
72288-056-62basic care nighttime cold and flu2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED23
72288-056-62basic care nighttime cold and flu12 in 1 CARTONCAPSULE, LIQUID FILLED123
72288-056-67basic care nighttime cold and flu24 in 1 CARTONCAPSULE, LIQUID FILLED243
72288-056-67basic care nighttime cold and flu2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-056BASIC CARE DAYTIME COLD AND FLU NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [AMAZON.COM SERVICES LLC]3Current NDC, Legacy NDC20241116_ceb342da-ff6d-4c19-9f78-0033d028075e.zip
72288-056BASIC CARE NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [AMAZON.COM SERVICES LLC]3Current NDC, Legacy NDC, 4 package rows20241017_f4497e56-c69d-4ae9-bd81-80bf2ee1b17f.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 41 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Simi Nighttime Cold and FluACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MGFarmacias De Similares TX LLC4e5772ee-586c-6191-e063-6294a90a132d2026-03-30WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HCLHyVee Inc75b19163-db1c-42fc-8bbb-364be16b9b2f2026-03-30WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEHyVee Inca9f23c63-eeda-4de9-aec6-fe482f469e982026-03-27WarningsExact identifier
application number: M012
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCHAIN DRUG MARKETING ASSOCIATION INC7d1b3418-85a8-4ca0-bca7-261b2b58032a2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD, FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Inc.bfc38500-5706-0d03-e053-2995a90a5c722026-03-26WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP2baa0861-dbef-7910-e063-6394a90a117e2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEFACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCLCVS Pharmacy, Inc.c17d5ba7-3302-7931-e053-2a95a90a5a6c2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy, Inc.c17b8f17-95f6-37e4-e053-2995a90a411a2026-03-26WarningsExact identifier
application number: M012
Ultra concentrated Daytime/ Nighttime Severe SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGELCVS PHARMACY, INC24cedaec-06a6-8fde-e063-6394a90a3d7a2026-03-26WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEY SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.23079537-1c06-1373-e063-6394a90a37d22026-03-26WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS MENTHOL SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f2fa8c-071f-50ab-e063-6394a90a4a4a2026-03-26WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3618ccf0-1f30-42e0-bb50-bfa45cf2b5832026-03-26WarningsExact identifier
application number: M012
Vicks childrens Cough Congestion NightPHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company87231460-8b45-b995-e053-2a91aa0a6c432026-03-26WarningsExact identifier
application number: M012
VICKS CHILDRENS COUGH CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyf1d67797-c806-261d-e053-2a95a90a3c152026-03-26WarningsExact identifier
application number: M012
childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHyVee Inc686f43ea-4296-4eee-b762-9a9e683443402026-03-26WarningsExact identifier
application number: M012
Tussin DM NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59d3a486-97c2-4e60-90e2-1b5bfa7638c72026-03-26WarningsExact identifier
application number: M012
flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRMeijer Distribution Inc1a853e47-21a2-40e1-9e64-290af4843b132026-03-25WarningsExact identifier
application number: M012
cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Incc4dcc427-aeec-4a26-80f3-02a4b227a5202026-03-25WarningsExact identifier
application number: M012
Walgreens Lavender Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company327a1a00-852d-2756-e063-6394a90a5e292026-03-25WarningsExact identifier
application number: M012
Walgreens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company2d56ddcd-3cc8-51eb-e063-6394a90ae7452026-03-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCKceb342da-ff6d-4c19-9f78-0033d028075e3
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSNceb342da-ff6d-4c19-9f78-0033d028075e3
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNceb342da-ff6d-4c19-9f78-0033d028075e3
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNceb342da-ff6d-4c19-9f78-0033d028075e3
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNf4497e56-c69d-4ae9-bd81-80bf2ee1b17f3
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDceb342da-ff6d-4c19-9f78-0033d028075e3
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDceb342da-ff6d-4c19-9f78-0033d028075e3
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDf4497e56-c69d-4ae9-bd81-80bf2ee1b17f3
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSYceb342da-ff6d-4c19-9f78-0033d028075e3
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYceb342da-ff6d-4c19-9f78-0033d028075e3
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYceb342da-ff6d-4c19-9f78-0033d028075e3
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYf4497e56-c69d-4ae9-bd81-80bf2ee1b17f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-056-00722880056008 in 1 CARTONHistorical
72288-056-627228800566212 BLISTER PACK in 1 CARTON (72288-056-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK12 blister pack2021-09-070000-00-00NoNoCurrent
72288-056-677228800566724 BLISTER PACK in 1 CARTON (72288-056-67) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK24 blister pack2020-12-280000-00-00NoNoCurrent