FDA.reportPublic FDA data

ALKA SELTZER PLUS Cold Day and Night Effervescent

Product NDC
71992-154
11-digit product format
719920154
Labeler code
71992
Product ID
71992-154_086318bd-5067-477e-e063-6294a90ab2dd
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE
Dosage form
TABLET
Route
ORAL
Labeler
Sincronia Logistica, S.A. de C.V.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-02
Substance
ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE
Active strength
325; 10; 7.8 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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
ALKA SELTZER PLUS Cold Day and Night Effervescent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
PHENYLEPHRINE BITARTRATE7.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
27O3Q5ML57Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1536498Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c478df69-823a-4112-8f44-323249a9f38fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71992-154-20ALKA SELTZER PLUS Cold Day and Night Effervescent20 in 1 CARTONTABLET204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71992-154ALKA SELTZER PLUS COLD DAY AND NIGHT EFFERVESCENT (ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) TABLET [SINCRONIA LOGISTICA, S.A. DE C.V.]4Current NDC, Legacy NDC, 1 package rows20231024_c478df69-823a-4112-8f44-323249a9f38f.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 168 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu ExpressMax Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC62f7fcb9-e31a-4634-b1c2-44a9567e3a612024-03-07WarningsExact identifier
application number: M012
Theraflu ExpressMax Severe Cold and Flu CapletsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHaleon US Holdings LLC8e22f6bc-33ce-4bb0-99be-7947aa21f60e2024-03-07WarningsExact identifier
application number: M012
Theraflu ExpressMax Severe Cold and Flu SyrupACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHaleon US Holdings LLC777d2ac7-e3cc-4513-8b6f-b90b2ff2c6722024-03-07WarningsExact identifier
application number: M012
Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS Pharmacy4c6025ff-4982-4408-b077-75dd5f5b65b22024-03-07WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacy423fd5e6-5d90-4539-81e0-0ae23881ee3a2024-03-07WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy917df706-1982-4240-9f56-42d426b76cc52024-03-06WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)21a29998-29d6-4a36-a370-291d23bfb1972024-03-05WarningsExact identifier
application number: M012
Multi-Symptom Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)3c7ef3cf-f7f9-42bc-bf20-e36954b9671f2024-03-05WarningsExact identifier
application number: M012
QUALITY CHOICE NightTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.da06e994-6848-4c1e-9432-31de5e626ea42024-03-02WarningsExact identifier
application number: M012
QUALITY CHOICE DayTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.417c4fa9-6458-40d0-b22a-2415194e250f2024-03-02WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAurohealth LLC8eaa0eec-cc52-4f1f-8ddb-06c54d577ce22024-03-01WarningsExact identifier
application number: M012
APRODINEPSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLA-S Medication Solutionsbbc268b8-fa66-4dc5-b935-f77ae39d28c82024-02-29WarningsExact identifier
application number: M012
XtraCare Vaporizing Chest RubCAMPHOR, MENTHOLRejoice Internationalc3e220d6-fff4-452f-99a9-bd701fc608a02024-02-28WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime Berry BurstACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCebbb2f4b-ba84-40ad-96f6-60225119a33b2024-02-27WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAMERISOURCE BERGEN1c93c45d-1141-4599-83ba-6d3b38f9ffc42024-02-23WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen3dc293c9-736b-4bd8-b993-ff83b9909bcd2024-02-23WarningsExact identifier
application number: M012
Childrens Dibromm Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCardinal Health (Leader) 7000010cc7d67-30c4-4451-bf74-78abae3c8e252024-02-23WarningsExact identifier
application number: M012
Nasal Spray, 24-7 for LifeOXYMETAZOLINE HYDROCHLORIDE 0.05%Lil' Drug Store Products, Inc.11d27c75-fd95-f9da-e063-6394a90ac6b02024-02-20WarningsExact identifier
application number: M012
Nighttime Cold and Cough childrensDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)11652e8a-2242-4449-8a41-a8e75509025e2024-02-20WarningsExact identifier
application number: M012
Severe Sinus Relief MistOXYMETAZOLINE SPRAYWalgreens Company847f47d9-62b1-49a3-8bb3-9bf275685bd22024-02-14WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536498aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletPSNc478df69-823a-4112-8f44-323249a9f38f4
1536498aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSCDc478df69-823a-4112-8f44-323249a9f38f4
1536498ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSYc478df69-823a-4112-8f44-323249a9f38f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71992-154-207199201542020 TABLET in 1 CARTON (71992-154-20) 20 tablet2018-07-020000-00-00NoNoCurrent