Cold and Allergy

Product NDC
55910-890
Requested package NDC
55910-890-48
11-digit product format
559100890
Labeler code
55910
Product ID
55910-890_cc4139a9-99ac-452d-bde3-2df5da7ca8f7
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-04-30
Marketing end
2024-01-26
Substance
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
4 mg/1; mg/1
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 packagepackage55910-89055910-890-48DDiscontinued by firm2026-10-05

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
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZCOLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UCOLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCOLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCOLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BCOLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOLD AND ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-890-48559100890482 BLISTER PACK in 1 CARTON (55910-890-48) > 24 TABLET in 1 BLISTER PACK2 blister pack2013-04-302024-01-26NoNoCurrent