FDA.reportPublic FDA data

Night Time Severe Cold and Cough Relief

Product NDC
68016-154
11-digit product format
680160154
Labeler code
68016
Product ID
68016-154_2f8462e8-7096-4688-ba3d-14caae022944
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL
Dosage form
LIQUID
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-10-04
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68016-154-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68016-154-08DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68016-154-08DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68016-154-08IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68016-154-08IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
Night Time Severe Cold and Cough Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/15mL
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1298348Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8e9b57b-83e9-46c5-9791-02c4c2b94004Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-154-082020-12-31C16284748780-19d75b9cf-e2ac-f424-e053-dadaa90a57cec8e9b57b-83e9-46c5-9791-02c4c2b94004
68016-154-082020-01-31C16284748780-19d75b9cf-e2ac-f424-e053-dadaa90a57cec8e9b57b-83e9-46c5-9791-02c4c2b94004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-154-08Night Time Severe Cold and Cough Relief245 mL in 1 BOTTLELIQUID2455

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-154-08ML - Milliliter68016-154e0cb6fb2-4c63-4c83-9380-9d5f2aedba8d12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJNIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVNIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
MALTITOLINACTIVE INGREDIENTD65DG142WKNIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RNIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-154NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]5Current NDC, Legacy NDC, 1 package rows20241231_c8e9b57b-83e9-46c5-9791-02c4c2b94004.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 74 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOW DOSE ASPIRINASPIRINBryant Ranch Prepack64c28b38-23bb-4c7e-9c19-1d1f0d5975282024-01-18WarningsExact identifier
application number: M013
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLCe0dd4c04-6811-38a1-e053-2995a90aa3c92024-01-17WarningsExact identifier
application number: M013
Regular Strength AcetaminophenACETAMINOPHENCARDINAL HEALTHbdf8c511-ce25-0e30-e053-2a95a90a33f62024-01-10WarningsExact identifier
application number: M013
Extra Strength Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2560126e-a54a-4a47-9631-a1bca42f52772024-01-10WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINA-S Medication Solutionsee4451c9-4d0f-4373-8f64-fcc1f9dd58562024-01-05WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP51ba690e-d76b-41c6-a083-8bc803e1faa22024-01-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-Aspirin Extra StrengthACETAMINOPHENProficient Rx LP9071b047-5463-4f65-b775-bfb0ce0665272024-01-01WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINTIME CAP LABORATORIES, INC1acc8c1a-c746-4635-800c-de1ad758fce02023-12-30WarningsExact identifier
application number: M013
MAX Cold, Flu, and Sore ThroatACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCLH E B9b09b660-0758-48dc-84c9-26cdd2aacc032023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU OriginalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Basketeb24323f-82a1-4ba3-9359-fe81571c3fba2023-12-29WarningsExact identifier
application number: M013
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRYACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.e6c3e545-b2ad-47f0-8318-c134a8e24f5b2023-12-29WarningsExact identifier
application number: M013
Daytime Non-Drowsy COLD/FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESalado Sales, Inc.e181b371-78c7-4163-865d-acc064be33ca2023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever Cherry flavorACETAMINOPHENWalgreen Company64c65244-f7a3-401b-b83a-bf66d45268e22023-12-29WarningsExact identifier
application number: M013
Nite-Time COLD/FLU ORIGINALACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.fcd24753-b42b-4d05-8379-0ec0351ab2172023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU CherryACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Baskete772cdf5-d01d-4752-8cfb-7e7f4d7a8dd02023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever, Grape flavorACETAMINOPHENWalgreen Company0995d69f-61aa-40b0-b095-bb8595caf7732023-12-29WarningsExact identifier
application number: M013
DAY-TIME Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketce900e42-d0c8-408d-a1c3-3a9bef1c97ee2023-12-29WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLDOLGENCORP, INC.06553550-5685-f3c3-e063-6394a90aef072023-12-22WarningsExact identifier
application number: M013
Tension Headache Pain Relieving AidACETAMINOPHEN,CAFFEINEWAL-MART STORES INC00fadd26-a6eb-dc5e-e063-6394a90a3cca2023-12-15WarningsExact identifier
application number: M013
Dye-Free Aspirin 81ASPIRINWALGREENSd71a9d3a-cd28-14a8-e053-2995a90a832b2023-12-15WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298348acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNc8e9b57b-83e9-46c5-9791-02c4c2b940045
1298348acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDc8e9b57b-83e9-46c5-9791-02c4c2b940045
1298348acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYc8e9b57b-83e9-46c5-9791-02c4c2b940045
1298348acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYc8e9b57b-83e9-46c5-9791-02c4c2b940045
1298348APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSYc8e9b57b-83e9-46c5-9791-02c4c2b940045

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-154-0868016015408245 mL in 1 BOTTLE (68016-154-08) 245 ml2013-10-040000-00-00NoNoCurrent