Cold and Allergy

Product NDC
69168-302
11-digit product format
691680302
Labeler code
69168
Product ID
69168-302_3c806cbf-7a22-473e-a56f-6622d4da7d78
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl and Chlorpheniramine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-12-23
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength
10 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69168-302DDiscontinued by firm2026-10-20
excluded packagepackage69168-30269168-302-93DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69168-302-93d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69168-302-93f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69168-302-932ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69168-302-93a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69168-302-93cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69168-302-93cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69168-302-93302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69168-302-93ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69168-302-930efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69168-302-93ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69168-302-93367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69168-302-93557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69168-302-932020-03-13C16284748780-19d75b9d0-7531-f424-e053-dadaa90a57ceDrug Facts
69168-302-932020-01-31C16284748780-19d75b9d0-7531-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZCOLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UCOLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPCOLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCOLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BCOLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-302-93691680302931 BLISTER PACK in 1 CARTON (69168-302-93) > 24 TABLET in 1 BLISTER PACK1 blister pack2014-12-230000-00-00NoNoCurrent