Sinus Headache PE Non- Drowsy

Product NDC
41520-270
Requested package NDC
41520-270-24
11-digit product format
415200270
Labeler code
41520
Product ID
41520-270_56be3c3a-173a-418f-8d53-d3c9df9dbf75
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
American Sales Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-12
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage41520-27041520-270-24DDiscontinued by firm2026-10-20

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 · 11 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…

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 INGREDIENT362O9ITL9DSINUS HEADACHE PE MAXIMUM STRENGHT NON- DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [AMERICAN SALES COMPANY]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS HEADACHE PE MAXIMUM STRENGHT NON- DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [AMERICAN SALES COMPANY]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS HEADACHE PE MAXIMUM STRENGHT NON- DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [AMERICAN SALES COMPANY]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS HEADACHE PE MAXIMUM STRENGHT NON- DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [AMERICAN SALES COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS HEADACHE PE MAXIMUM STRENGHT NON- DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [AMERICAN SALES COMPANY]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KSINUS HEADACHE PE MAXIMUM STRENGHT NON- DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [AMERICAN SALES COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASINUS HEADACHE PE MAXIMUM STRENGHT NON- DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [AMERICAN SALES COMPANY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSINUS HEADACHE PE MAXIMUM STRENGHT NON- DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [AMERICAN SALES COMPANY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSINUS HEADACHE PE MAXIMUM STRENGHT NON- DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [AMERICAN SALES COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSINUS HEADACHE PE MAXIMUM STRENGHT NON- DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [AMERICAN SALES COMPANY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-270-244152002702424 TABLET in 1 BLISTER PACK (41520-270-24) 24 tablet2014-06-120000-00-00NoNoCurrent