FDA.reportPublic FDA data

COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct

Product NDC
76162-678
11-digit product format
761620678
Labeler code
76162
Product ID
76162-678_f108e17b-8973-49d8-9d1d-5781170f9b4b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Doxylamine Succinate, Phenylephrine Hydrochloride
Dosage form
KIT
Labeler
Topco Associates LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-11
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
COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct
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
1297288Internal RxNorm lookup
1656815Internal RxNorm lookup
2634364Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3eAvailable 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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-678-24COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct1 in 1 CARTONKIT12

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 136 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SanaTos BoostDEXTROMETHORPHAN HBRPharmadel LLCae6a424f-f3f0-3f6c-e053-2995a90a972d2024-11-18WarningsExact identifier
application number: M012
SanaTos Turbo Max StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLPharmadel LLCd56a071c-a747-5397-e053-2995a90aad8b2024-11-18WarningsExact identifier
application number: M012
equaline childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa24021a0-ef68-4bce-ba53-d262d1025cc02024-11-17WarningsExact identifier
application number: M012
Cold and Cough DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Inc4d5f93c1-7752-4948-ba58-c4385cfc24c82024-11-17WarningsExact identifier
application number: M012
Good Sense Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company8a87104f-94a4-4585-afd5-d610eea32e392024-11-17WarningsExact identifier
application number: M012
equate childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Incc91e94f4-4c51-4fe7-ad2e-0b9dc58b51e42024-11-17WarningsExact identifier
application number: M012
foster and thrive childrens allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEStrategic Sourcing Services LLC1eac715b-351c-4b47-8d1d-6e921813c1a42024-11-15WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC298d2796-5ae5-4346-b6d2-2ced2dd29dc32024-11-15WarningsExact identifier
application number: M012
dg health day time severe cold and flu relief night time severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEDolgencorp, LLCf721b393-9ad5-4fc6-a2c5-bd89e58caf162024-11-15WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f22024-11-15WarningsExact identifier
application number: M012
Rompe Pecho EXGUAIFENESINEfficient Laboratories Inc89ea23a5-0da7-407e-83d9-77a0b562f3af2024-11-14WarningsExact identifier
application number: M012
basic care daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLCceb342da-ff6d-4c19-9f78-0033d028075e2024-11-14WarningsExact identifier
application number: M012
Topcare Nite Time Day Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLCefb8e0e2-0795-4f4a-8ca6-955f33bee1432024-11-14WarningsExact identifier
application number: M012
good neighbor pharmacy nasal fourPHENYLEPHRINE HYDROCHLORIDEAmerisource Bergena3d637dc-d957-458c-8a75-f948601a31aa2024-11-14WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEMeijer Distribution Incec8db98f-4fd1-4644-b76f-ff04f72e87f42024-11-13WarningsExact identifier
application number: M012
dg health tussinDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, LLC6f9b8267-1e0b-430b-8e44-06408ae82ea42024-11-13WarningsExact identifier
application number: M012
Walgreens Effervescent Cold Relief PlusASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEWalgreensb60e2cf9-11ec-469e-e053-2a95a90a712a2024-11-13WarningsExact identifier
application number: M012
Kroger Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEKroger Company69333774-3cf4-384d-e053-2a91aa0a48b32024-11-13WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEH. E. Butt Grocery Company6403fe3d-d82b-f4d5-e053-2991aa0ac7d62024-11-13WarningsExact identifier
application number: M012
Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATETopco Associates LLCa2929bcb-fa81-4f15-b087-a9996b5e7d1f2024-11-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634364{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 / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCKceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 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) PackPSNceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSNceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSNceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 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) PackSYceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-678-24761620678241 KIT in 1 CARTON (76162-678-24) * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 kit2025-12-11NoNoCurrent