Alka-Seltzer Plus

Product NDC
66715-9735
11-digit product format
667159735
Labeler code
66715
Product ID
66715-9735_e7a207e4-797f-08b4-e053-2a95a90af329
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin, Chlorpheniramine Maleate, and Phenylephrine Bitartrate
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Lil' Drug Store Products, Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2000-01-01
Marketing end
2025-06-09
Substance
ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE
Active strength
325 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66715-9735DDiscontinued by firm2026-10-05
excluded packagepackage66715-973566715-9735-1DDiscontinued by firm2026-10-05
excluded packagepackage66715-973566715-9735-2DDiscontinued 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 · 14 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 packagepackage66715-9735-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66715-9735-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66715-9735-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66715-9735-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66715-9735-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66715-9735-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66715-9735-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66715-9735-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66715-9735-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66715-9735-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66715-9735-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66715-9735-1ad56d346431e…cc804d4bbf1e…

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
AspirinACTIVE INGREDIENTR16CO5Y76EALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
Chlorpheniramine MaleateACTIVE INGREDIENTV1Q0O9OJ9ZALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
Phenylephrine BitartrateACTIVE INGREDIENT27O3Q5ML57ALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
AspirinACTIVE MOIETYR16CO5Y76EALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
ChlorpheniramineACTIVE MOIETY3U6IO1965UALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
PhenylephrineACTIVE MOIETY1WS297W6MVALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
Acesulfame PotassiumINACTIVE INGREDIENT23OV73Q5G9ALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
AspartameINACTIVE INGREDIENTZ0H242BBR1ALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
Calcium SilicateINACTIVE INGREDIENTS4255P4G5MALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1OALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
Docusate SodiumINACTIVE INGREDIENTF05Q2T2JA0ALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
MannitolINACTIVE INGREDIENT3OWL53L36AALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
PovidonesINACTIVE INGREDIENTFZ989GH94EALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QOALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9735ALKA-SELTZER PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC]5Legacy NDC20220903_cb87be72-e0c5-4491-85b5-b9b8d7d269cb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9735-1667159735011 POUCH in 1 CARTON (66715-9735-1) > 2 TABLET, EFFERVESCENT in 1 POUCH1 pouch2000-01-010000-00-00NoNoCurrent
66715-9735-2667159735022 POUCH in 1 CARTON (66715-9735-2) > 2 TABLET, EFFERVESCENT in 1 POUCH2 pouch2000-01-010000-00-00NoNoCurrent