FDA.reportPublic FDA data

Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu

Product NDC
0280-0040
11-digit product format
002800040
Labeler code
0280
Product ID
0280-0040_452615d3-7d63-4fa6-e063-6394a90a5dfd
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride, doxylamine succinate
Dosage form
KIT
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-26
NDC exclude flag
No
Listing certified through
2026-12-31
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 Maximum Strength Day and Night Cold and Flu
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086997Internal RxNorm lookup
1297288Internal RxNorm lookup
2634363Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b13d5132-cb91-3cf6-e053-2a95a90aa47cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0040-01Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu1 in 1 CARTONKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0040ALKA-SELTZER PLUS MAXIMUM STRENGTH DAY AND NIGHT COLD AND FLU (DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE LLC.]4Current NDC, Legacy NDC, 1 package rows20241210_b13d5132-cb91-3cf6-e053-2a95a90aa47c.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 171 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BanophenDIPHENHYDRAMINE HCLA-S Medication Solutionse1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd2024-01-08WarningsExact identifier
application number: M012
AXIM DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINVIVUNT PHARMA LLC0e7424ea-461f-5ead-e063-6294a90a41b62024-01-05WarningsExact identifier
application number: M012
AXIM Night Time - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC0e740063-80d5-c48b-e063-6394a90a3b302024-01-05WarningsExact identifier
application number: M012
AXIM DayTime - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC0e742e10-daea-6443-e063-6294a90ab5af2024-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3c3e0dc8-cddd-4f46-9b68-19bac00c07cc2024-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLA-S Medication Solutionsfa12a5a8-bf2d-4991-9d54-9c519e8e04cd2024-01-04WarningsExact identifier
application number: M012
NASAL DECONGESTANT PE 10mgPHENYLPHRINE HCLYYBA CORP05824fc4-ef3f-4ebb-b601-252f76ad60ef2024-01-03WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLProficient Rx LP5943d975-77e4-4cbd-b2d9-d699052fe82a2024-01-01WarningsExact identifier
application number: M012
Coricidin HBP Cold and FluACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEProficient Rx LPac79a7dd-c26e-47d2-8fb9-768d2d09e5072024-01-01WarningsExact identifier
application number: M012
Oxymethazoline HCLOXYMETHAZOLINE HCLProficient Rx LP96883e5f-18b5-4c1c-b984-756cb86be6ff2024-01-01WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLProficient Rx LP6e91b9c3-57e8-488b-ac70-d863cdf9d6e82024-01-01WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEProficient Rx LP9e067482-8735-4476-a82e-438dd24d42892024-01-01WarningsExact identifier
application number: M012
XL-3 Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.94e02be4-b8a6-422a-8f66-e6a69e924b2c2023-12-30WarningsExact identifier
application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DMDEXTROMETHORPHAN HYDROBROMIDEAptaPharma Inc.8a4c55d0-c472-4e89-9fdb-17ecf0af48562023-12-30WarningsExact identifier
application number: M012
XL-3 XtremeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAptaPharma Inc.dff79e0b-edf0-4dd3-a722-fd9beecd62932023-12-30WarningsExact identifier
application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSalado Sales, Inc.e25727d0-7dd7-4ef5-b064-7938679f075f2023-12-29WarningsExact identifier
application number: M012
Maximum Strength DM MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINH E Bbb56d09d-ecb0-469e-a16f-f9f1a48942a82023-12-29WarningsExact identifier
application number: M012
Childrens Cough Mucus ReliefDEXTROMETHORPHANN HBR, GUAIFENESINDiscount Drug Mart2c27aca4-e1e2-419a-84c4-857718ca49da2023-12-29WarningsExact identifier
application number: M012
Night Time Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Companyde2b2e34-62a5-451f-ab68-531d1c9d4d822023-12-29WarningsExact identifier
application number: M012
H E B MAX SEVERE CONGESTION and COUGH Maxium StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E Bd2b016ee-5329-45bf-9d71-d626204169cf2023-12-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634363{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCKb13d5132-cb91-3cf6-e053-2a95a90aa47c5
26343631 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSNb13d5132-cb91-3cf6-e053-2a95a90aa47c5
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSNb13d5132-cb91-3cf6-e053-2a95a90aa47c5
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNb13d5132-cb91-3cf6-e053-2a95a90aa47c5
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDb13d5132-cb91-3cf6-e053-2a95a90aa47c5
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDb13d5132-cb91-3cf6-e053-2a95a90aa47c5
26343631 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSYb13d5132-cb91-3cf6-e053-2a95a90aa47c5
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYb13d5132-cb91-3cf6-e053-2a95a90aa47c5
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYb13d5132-cb91-3cf6-e053-2a95a90aa47c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-0040-01002800040011 KIT in 1 CARTON (0280-0040-01) * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 kit2020-10-260000-00-00NoNoCurrent