FDA.reportPublic FDA data

Flu and Sore Throat

Product NDC
15127-862
Requested package NDC
15127-862-08
11-digit product format
151270862
Labeler code
15127
Product ID
15127-862_e8fa7b6e-9d2b-4fc8-9627-ffad9732160b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Select Brand Dist.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-09-08
Marketing end
2021-12-30
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage15127-86215127-862-08DDiscontinued by firm2026-10-15

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40FLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9FLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
MALTITOLINACTIVE INGREDIENTD65DG142WKFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2
WATERINACTIVE INGREDIENT059QF0KO0RFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SELECT BRAND DIST.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15127-862-0815127086208245 mL in 1 BOTTLE, PLASTIC (15127-862-08) 245 ml2010-09-082021-12-30NoNoCurrent