FDA.reportPublic FDA data

ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night

Product NDC
0280-8284
11-digit product format
002808284
Labeler code
0280
Product ID
0280-8284_53715ea4-42b4-5887-e063-6294a90a4249
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, and Doxylamine succinate
Dosage form
KIT
Labeler
Bayer HealthCare LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-01
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 COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1534835Internal RxNorm lookup
1550968Internal RxNorm lookup
1804384Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53715ea4-42b3-5887-e063-6294a90a4249Available on FDA.report

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 126 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens TussnexACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company19e9678d-ac34-4af8-a80f-d08fce0a5f0e2024-12-19WarningsExact identifier
application number: M012
Vaporising Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILNew Pride Corpf66476d5-036b-0b1c-e053-2a95a90a0a072024-12-19WarningsExact identifier
application number: M012
Chest Rub Vaporizing ActionMENTHOL AND CAMPHOR AND EUCALYPTUS OILSinghfam Corporationc6ea663a-9c4f-4d1a-a937-002806a8530a2024-12-19WarningsExact identifier
application number: M012
ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTIONCAMPHOR (SYNTHETIC), LEVOMENTHOL, EUCALYPTUSSinghfam Corporationf1e4caee-b50e-a0a6-e053-2a95a90aadce2024-12-19WarningsExact identifier
application number: M012
Leader Vapor Steam camphor (synthetic)CAMPHOR (SYNTHETIC)LEADER/Cardinal Health 110, Inc.ae580e6c-2efd-c788-e053-2995a90a33602024-12-19WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINStrategic Sourcing Service, LLC0b6689db-ea34-9a06-e063-6394a90abaf72024-12-19WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILJell Pharmaceuticals Pvt Ltd.d80b9cc1-55f5-76d5-e053-2995a90aa9672024-12-19WarningsExact identifier
application number: M012
Health Smart Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUS OILHome Smart Productsacab200e-48bd-69e1-e053-2995a90afde02024-12-19WarningsExact identifier
application number: M012
Halls MENTHO-LYPTUSMENTHOLMondelez Global LLCff21cf0e-9811-4819-bdfc-17a950e9b1142024-12-19WarningsExact identifier
application number: M012
Tussnex FM Cold, Flu and Sore ThroatACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company7bddce11-c227-4d95-94c1-6f41ecd7285b2024-12-19WarningsExact identifier
application number: M012
Childrens Tussnex Multi-symptom coldDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company9028676e-d725-4afe-aa14-72235825aa172024-12-19WarningsExact identifier
application number: M012
Tussnex FM Cold and SinusACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company04c6bb6a-d2f8-4322-afba-e240e80901762024-12-19WarningsExact identifier
application number: M012
Tussnex FM Severe cough and congestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company387df403-7803-4031-915e-8de9b103a1622024-12-19WarningsExact identifier
application number: M012
Maximum strength Tussnex FM DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINGuardian Drug Company0bae53e3-9661-4bc6-9fcc-da7fa131b0342024-12-19WarningsExact identifier
application number: M012
Vicks Vaposteam LavenderCAMPHOR, (-)-Kaz USA, Inc03bf6b78-cf8e-44c6-bae0-5bd0a85f8aa92024-12-19WarningsExact identifier
application number: M012
Refenesen Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINReese Pharmaceutical Co6046dc50-f162-4e2d-aa3c-7d27efad477d2024-12-18WarningsExact identifier
application number: M012
Sunmark Chest Congestion Relief PE PEGUAIFENESIN/PHENYLEPHRINEStrategic Sourcing Services LLCf94ae469-4c79-4ce9-9a3d-3bdc645be6d92024-12-18WarningsExact identifier
application number: M012
Quality Choice Mucus Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINChain Drug Marketing Association1c33a01f-1186-4a19-b639-a9cd492452202024-12-18WarningsExact identifier
application number: M012
HealthMart Chest Congestion ReliefGUAIFENESINStrategic Sourcing Services LLCa5d1a8e8-10ba-4fff-b6f7-18c0fde5155c2024-12-18WarningsExact identifier
application number: M012
DG Health Immediate Release Mucus ReliefGUAIFENESINReese Pharmaceutical Cof60a9d1b-7a63-43d3-b843-e1f31cf788732024-12-18WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0280-8284-12002808284121 KIT in 1 CARTON (0280-8284-12) * 1 POWDER, FOR SOLUTION in 1 PACKET * 1 POWDER, FOR SOLUTION in 1 PACKET1 kit2026-06-01NoNoCurrent