FDA.reportPublic FDA data

HISTEX AC

Product NDC
28595-250
Requested package NDC
28595-250-16
11-digit product format
285950250
Labeler code
28595
Product ID
28595-250_07d6bef9-8aa3-43f5-b903-63a06ff7136f
Type
HUMAN OTC DRUG
Nonproprietary name
CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, and TRIPROLIDINE HYDROCHLORIDE
Dosage form
SYRUP
Route
ORAL
Labeler
Allegis Pharmaceuticals, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-12
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength
10 mg/5mL; mg/5mL; mg/5mL
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage28595-25028595-250-16DDiscontinued 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-250-16ML - Milliliter28595-2506a4f92cc-d9d8-4d17-9cf7-2c94cff3cdd512015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6HISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
TRIPROLIDINE HYDROCHLORIDEACTIVE INGREDIENTYAN7R5L890HISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JHISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
TRIPROLIDINEACTIVE MOIETY2L8T9S52QMHISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFHISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4HISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RHISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4HISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHISTEX AC (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
28595-250-1628595025016473 mL in 1 BOTTLE (28595-250-16) 473 ml2015-08-120000-00-00NoNoCurrent