FDA.reportPublic FDA data

Cold Plus Head Congestion Day and Night

Product NDC
36800-927
11-digit product format
368000927
Labeler code
36800
Product ID
36800-927_286004ce-751f-a742-e063-6394a90acd0c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
Dosage form
KIT
Labeler
TopCo Associates LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-30
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
Cold Plus Head Congestion Day and Night
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
1086991Internal RxNorm lookup
1094538Internal RxNorm lookup
2634560Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
898eb1c7-395a-4845-9d0a-719fc78d86b7Available 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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-927-02Cold Plus Head Congestion Day and Night1 in 1 CARTONKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-927COLD PLUS HEAD CONGESTION DAY AND NIGHT (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 1 package rows20241208_898eb1c7-395a-4845-9d0a-719fc78d86b7.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 154 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
oxymetazoline hclOXYMETAZOLINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltda1103cd8-344b-4a65-8a60-3c7be86d01a62024-09-11WarningsExact identifier
application number: M012
Good Sense NasalOXYMETAZOLINE HYDROCHLORIDEL. Perrigo Company276d7d3c-c4a7-4754-8845-c38f85aac5f72024-09-08WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDEStrategic Sourcing Services LLC4ff5a4ae-9649-4a6d-a5f8-ca23efbbb4792024-09-08WarningsExact identifier
application number: M012
equate nasal originalOXYMETAZOLINE HYDROCHLORIDEWal-Mart Stores Inc7e40c9b8-e0b5-448a-a674-72388fbab1892024-09-08WarningsExact identifier
application number: M012
Anefrin Nasal OriginalOXYMETAZOLINE HYDROCHLORIDEWalgreen Company85b442dc-1703-4fef-948a-fad7cbe9f2242024-09-07WarningsExact identifier
application number: M012
equaline nasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI07e0328e-1912-4f25-9e1e-9482d4665be02024-09-07WarningsExact identifier
application number: M012
Benadryl Allergy EXTRA STRENGTHDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCdd0a8069-18d8-5696-e053-2995a90a2f222024-09-06WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEPAI Holdings, LLC88d0994c-4270-4408-8837-bd97510b21182024-09-06WarningsExact identifier
application number: M012
QCH Maximum Strength Mucus Relief 617DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association Inc.a1c5c15e-0f3a-47d3-b9ed-1e00184175142024-09-06WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Nighttime Soft ChewsACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC6ba64bbe-7599-406a-9187-737c0f8c1c2a2024-09-05WarningsExact identifier
application number: M012
Cough Relief NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)344282fc-3bd1-4f49-9bd1-08c5a58d1f732024-09-05WarningsExact identifier
application number: M012
Equate NasalPHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc95ef1819-edc3-4dda-8514-85b61538cc722024-09-04WarningsExact identifier
application number: M012
Up and up nasalOXYMETAZOLINE HYDROCHLORIDETarget Corporation0c246c11-eadd-4ac6-bd58-5fdb151e06d62024-09-04WarningsExact identifier
application number: M012
Exchange Select NasalOXYMETAZOLINE HYDROCHLORIDEArmy & Air Force Exchange Serviceaafa9163-f08e-48c9-9ca1-7b72f67d007d2024-08-31WarningsExact identifier
application number: M012
nasal 12 hourOXYMETAZOLINE HYDROCHLORIDEMeijer Distribution Ince9ee03db-a070-4c2b-ac61-7fd22bab27952024-08-31WarningsExact identifier
application number: M012
dg health nasalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLC42b58928-e8e5-49e4-b49e-498d77d64fcd2024-08-28WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HCLKroger Company0a24d98a-5950-49de-8b77-ea880b08d2c52024-08-28WarningsExact identifier
application number: M012
basic care no drip nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLC96e018e2-e0b5-4802-a4a1-73a73d5740822024-08-28WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HCLTopco Associates LLCb5434599-5485-4949-9d76-b1ef3ad17c1a2024-08-28WarningsExact identifier
application number: M012
basic care no drip nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCb15eb271-7842-495b-aa0f-9b20def86dc12024-08-28WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634560{1 (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } PackGPCK898eb1c7-395a-4845-9d0a-719fc78d86b75
26345601 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) PackPSN898eb1c7-395a-4845-9d0a-719fc78d86b75
1086991acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral TabletPSN898eb1c7-395a-4845-9d0a-719fc78d86b75
1094538acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral TabletPSN898eb1c7-395a-4845-9d0a-719fc78d86b75
1086991acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD898eb1c7-395a-4845-9d0a-719fc78d86b75
1094538acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD898eb1c7-395a-4845-9d0a-719fc78d86b75
26345601 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) PackSY898eb1c7-395a-4845-9d0a-719fc78d86b75
1086991APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSY898eb1c7-395a-4845-9d0a-719fc78d86b75
1094538APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSY898eb1c7-395a-4845-9d0a-719fc78d86b75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-927-02368000927021 KIT in 1 CARTON (36800-927-02) * 12 TABLET, COATED in 1 BLISTER PACK * 8 TABLET, COATED in 1 BLISTER PACK1 kit2011-08-300000-00-00NoNoCurrent