FDA.reportPublic FDA data

up and up

Product NDC
11673-113
11-digit product format
116730113
Labeler code
11673
Product ID
11673-113_39fadcca-6c94-39b8-e063-6394a90a89a2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Target Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-28
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 25; 10 mg/1; mg/1; mg/1
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
2026-12-31
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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11673-113-07ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11673-113-07367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11673-113-07557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11673-113-078af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11673-113-07834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11673-113-071332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11673-113-07fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11673-113-0786f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11673-113-07bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage11673-113-078dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage11673-113-07e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11673-113-079bebd1f3094a…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
up and up
Brand name suffix
nighttime flu and severe cold and cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

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
1659960Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df488727-b913-440b-9a0b-cce3ae143bf2Available 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
11673-113-072024-11-12C16284748780-19d75b9d1-20c7-f424-e053-dadaa90a57ceup & up nighttime flu and severe cold and cough
11673-113-072020-01-31C16284748780-19d75b9d1-20c7-f424-e053-dadaa90a57ceup & up nighttime flu and severe cold and cough

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-113-07up and upnighttime flu and severe cold and cough6 in 1 CARTONPOWDER, FOR SOLUTION64

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DUP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
Diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40UP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
Phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJUP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
AcetaminophenACTIVE MOIETY362O9ITL9DUP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
DiphenhydramineACTIVE MOIETY8GTS82S83MUP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
PhenylephrineACTIVE MOIETY1WS297W6MVUP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9UP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLUP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
anhydrous trisodium citrateINACTIVE INGREDIENTRS7A450LGAUP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
aspartameINACTIVE INGREDIENTZ0H242BBR1UP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GUP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDUP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOAUP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DUP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2
sucroseINACTIVE INGREDIENTC151H8M554UP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-113UP AND UP NIGHTTIME FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARGET CORPORATION]3Current NDC, Legacy NDC, 1 package rows20241114_df488727-b913-440b-9a0b-cce3ae143bf2.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 55 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief Extra StrengthDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4f33c1fb-150b-4083-a9a4-c0fbab4b61332026-01-27WarningsExact identifier
application number: M012
Cold and Flu Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution Inc5ca7dc60-af0c-47c6-b453-8b39c744eb5b2026-01-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inc2ce5f2af-cabc-466f-b0c5-256e6e6d4c882026-01-27WarningsExact identifier
application number: M012
Sinus Headache and Pain Day, Non-drowsyACETAMINOPHEN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEc33340c0-47d3-45e2-997b-3d9fb148900f2026-01-27WarningsExact identifier
application number: M012
Cold and Flu Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.b7501b59-d25a-49ec-9cbf-47018bce83972026-01-27WarningsExact identifier
application number: M012
good sense nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Companyf90bd64a-dd1a-4319-87cd-427d57f677ab2026-01-26WarningsExact identifier
application number: M012
Equate Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu PlusACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc547ff880-3d40-4a4a-84ee-cd0d5290a9b92026-01-26WarningsExact identifier
application number: M012
Maximum Strength Non Drowsy Day and Night Cold and FluMAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLUWAL-MART STORES INCd6a35fb8-1899-4da2-ad2b-0423e332845d2026-01-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINProdose, Inc.7e5de5b0-18f0-4807-8686-da9821f918ce2026-01-26WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Incb9fbf917-12b7-770f-e053-2995a90afe932026-01-26WarningsExact identifier
application number: M012
Maximum Strength Non Drowsy Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb58b2c36-a403-4dae-b3b2-f0ffd28a963b2026-01-26WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inc870e6bcb-84ab-45e0-ae57-08a9a182eb0b2026-01-26WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inceb8e83a4-981b-48a5-88f4-3a0ba358d3bc2026-01-26WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc8d2d765f-a7e3-40e6-b35d-0e8806a7ea592026-01-26WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU CHERRYPHENYLEPHRINE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATEWalgreen Company02a6781c-aa6f-8fb0-e063-6294a90a043d2026-01-26WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATEWalgreen Company02e5f475-4e9f-2856-e063-6294a90a21fd2026-01-26WarningsExact identifier
application number: M012
GNP Vapor Steam camphor (synthetic)CAMPHOR (SYNTHETIC)AmerisourceBergen0bcc55bf-9654-120b-e063-6394a90a59d12026-01-26WarningsExact identifier
application number: M012
S2RACEPINEPHRINE HYDROCHLORIDENephron Pharmaceuticals Corporationdd1b35c7-b23b-4b95-8162-df3d263fe32e2026-01-26WarningsExact identifier
application number: M012
SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d97c634-0975-42d5-8ade-2ed2018cfe9d2026-01-26WarningsExact identifier
application number: M012
GOOD SENSE NIGHT TIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEL. Perrigo Companycd68289b-3850-40c6-9439-aae0e2d7637d2026-01-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659960acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNdf488727-b913-440b-9a0b-cce3ae143bf24
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDdf488727-b913-440b-9a0b-cce3ae143bf24
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSYdf488727-b913-440b-9a0b-cce3ae143bf24
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSYdf488727-b913-440b-9a0b-cce3ae143bf24
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYdf488727-b913-440b-9a0b-cce3ae143bf24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
11673-113-07116730113076 POWDER, FOR SOLUTION in 1 CARTON (11673-113-07) 2013-06-28NoNoCurrent