FDA.reportPublic FDA data

Ultra concentrated Daytime/ Nighttime Severe Softgel

Product NDC
51316-547
11-digit product format
513160547
Labeler code
51316
Product ID
51316-547_4de9aabc-fafa-fd37-e063-6294a90ab10c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine hydrochloride softgel
Dosage form
KIT
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-01
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
Ultra concentrated Daytime/ Nighttime Severe Softgel
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
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
24cedaec-06a6-8fde-e063-6394a90a3d7aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
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103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
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42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
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c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-547-24Ultra concentrated Daytime/ Nighttime Severe Softgel2 in 1 CARTONKIT23
51316-547-24Ultra concentrated Daytime/ Nighttime Severe Softgel1 in 1 BLISTER PACKKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-547ULTRA CONCENTRATED DAYTIME/ NIGHTTIME SEVERE SOFTGEL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGEL) KIT [CVS PHARMACY, INC]2Current NDC, 2 package rows20250429_24cedaec-06a6-8fde-e063-6394a90a3d7a.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 159 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Deconex IRGUAIFENESIN AND PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.4710095e-3dae-4a39-8a98-873012e1f0032024-07-09WarningsExact identifier
application number: M012
Diabetic Tussin Sore Throat and Cough CherryBENZOCAINE AND DEXTROMETHORPHAN HBRMEDTECH PRODUCTS INCe9327079-e0fc-4c95-b1d5-bc1b74870c9b2024-07-09WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporationfac859a4-e23a-4879-af6c-26368455506d2024-07-05WarningsExact identifier
application number: M012
Severe Throat DropsMENTHOL ICETarget Corporation Inc.1876b221-fa60-5269-e063-6394a90a69632024-07-04WarningsExact identifier
application number: M012
Daytime and Nighttime Cherry Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0bf911bf-eafe-fe46-e063-6294a90a39032024-07-03WarningsExact identifier
application number: M012
Family Wellness Effervescent Cold Relief OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEFamily Dollar Services, Inc.4e13511b-fbb5-2523-e054-00144ff88e882024-07-03WarningsExact identifier
application number: M012
Nighttime Cherry Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATETARGET CORPORATION1c3f6cbf-a00d-45b9-e063-6394a90a797c2024-07-02WarningsExact identifier
application number: M012
Cold Terminator Cold ReliefPHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWildman Business Groupe8538d9c-f9ba-40b1-b60f-f57921f39b642024-07-01WarningsExact identifier
application number: M012
Nighttime Severe Honey Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION1c02e465-8750-a088-e063-6394a90a8efb2024-06-29WarningsExact identifier
application number: M012
ACTIDOM DMXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLC0166322e-7dbb-4658-a5c5-1d0525bb76552024-06-28WarningsExact identifier
application number: M012
ACTINEL DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLACTIPHARMA, LLC16660d82-524b-42ca-8581-48237caa13b22024-06-28WarningsExact identifier
application number: M012
PurgenLabs AcetaminophenACTAMINOPHENAdvanced Rx LLC915c4608-af1b-4119-8291-4ce9fd701d762024-06-28WarningsExact identifier
application number: M012
Daytime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCLTARGET CORPORATION1bc90b2f-612c-e977-e063-6294a90a40b42024-06-26WarningsExact identifier
application number: M012
Halls MentholyptusMENTHOLMondelez Global LLCf5292c5b-5608-4e13-afc2-4f3d7133da882024-06-25WarningsExact identifier
application number: M012
Halls StrawberryMENTHOLMondelez Global LLC75638f29-7f2a-46b0-b8a0-e87bc7d6eba12024-06-25WarningsExact identifier
application number: M012
Good Sense Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEA-S Medication Solutions5396a9cf-16eb-4628-9432-f49c67ffe2ce2024-06-25WarningsExact identifier
application number: M012
Nighttime Cold and Flu LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETARGET CORPORATION130ca5f1-2951-ec6f-e063-6394a90a754f2024-06-24WarningsExact identifier
application number: M012
Daytime and Nighttime Severe Honey Cold and FluDAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATETARGET CORPORATION08fd1513-30ab-15da-e063-6394a90ab57d2024-06-21WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe cold and fluDAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION0c0caa59-0637-bc33-e063-6294a90ae2442024-06-21WarningsExact identifier
application number: M012
Halls StrawberryMENTHOLMondelez Global LLCde401eb4-3282-4298-8a51-15d2682534642024-06-21WarningsExact 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) } PackGPCK24cedaec-06a6-8fde-e063-6394a90a3d7a3
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) PackPSN24cedaec-06a6-8fde-e063-6394a90a3d7a3
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN24cedaec-06a6-8fde-e063-6394a90a3d7a3
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN24cedaec-06a6-8fde-e063-6394a90a3d7a3
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD24cedaec-06a6-8fde-e063-6394a90a3d7a3
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD24cedaec-06a6-8fde-e063-6394a90a3d7a3
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) PackSY24cedaec-06a6-8fde-e063-6394a90a3d7a3
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY24cedaec-06a6-8fde-e063-6394a90a3d7a3
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY24cedaec-06a6-8fde-e063-6394a90a3d7a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-547-24513160547242 BLISTER PACK in 1 CARTON (51316-547-24) / 1 KIT in 1 BLISTER PACK * 8 CAPSULE in 1 BLISTER PACK * 4 CAPSULE in 1 BLISTER PACK2 blister pack2025-02-01NoNoCurrent