FDA.reportPublic FDA data

Alka-Seltzer Plus Cold Medicine Sparkling Original

Product NDC
0280-1400
11-digit product format
002801400
Labeler code
0280
Product ID
0280-1400_4526711d-1058-262c-e063-6294a90aef61
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-04-10
Substance
ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE
Active strength
325; 2; 7.8 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
2026-12-31
Current FDA listing
Yes

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0280-14000280-1400-12DDiscontinued by firm2026-10-16
excluded packagepackage0280-14000280-1400-20DDiscontinued by firm2026-10-16
excluded packagepackage0280-14000280-1400-36DDiscontinued by firm2026-10-16
excluded packagepackage0280-14000280-1400-48DDiscontinued by firm2026-10-16
excluded packagepackage0280-14000280-1400-72DDiscontinued by firm2026-10-16

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 · 60 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050280-1400-48d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050280-1400-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050280-1400-36d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050280-1400-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050280-1400-72d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260280-1400-72f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260280-1400-48f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260280-1400-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260280-1400-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260280-1400-36f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310280-1400-722ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310280-1400-482ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310280-1400-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310280-1400-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310280-1400-362ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280280-1400-72a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280280-1400-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280280-1400-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280280-1400-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280280-1400-36a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210280-1400-72cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210280-1400-48cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210280-1400-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210280-1400-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210280-1400-36cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100280-1400-72cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100280-1400-48cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100280-1400-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100280-1400-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100280-1400-36cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310280-1400-72302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310280-1400-48302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310280-1400-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310280-1400-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310280-1400-36302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200280-1400-72ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200280-1400-48ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200280-1400-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200280-1400-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200280-1400-36ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100280-1400-720efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100280-1400-480efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100280-1400-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100280-1400-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100280-1400-360efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080280-1400-72ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080280-1400-48ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080280-1400-12ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080280-1400-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080280-1400-36ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030280-1400-72367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030280-1400-48367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030280-1400-12367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030280-1400-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030280-1400-36367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090280-1400-72557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090280-1400-48557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090280-1400-12557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090280-1400-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090280-1400-36557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Alka-Seltzer Plus Cold Medicine Sparkling Original
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1
CHLORPHENIRAMINE MALEATE2 mg/1
PHENYLEPHRINE BITARTRATE7.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup
V1Q0O9OJ9ZInternal UNII lookup
27O3Q5ML57Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1536840Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
78537dcf-b157-4b67-a8b2-5cb144815166Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-1400-12Alka-Seltzer Plus Cold Medicine Sparkling Original2 in 1 POUCHTABLET, EFFERVESCENT29
0280-1400-12Alka-Seltzer Plus Cold Medicine Sparkling Original6 in 1 CARTONTABLET, EFFERVESCENT69
0280-1400-20Alka-Seltzer Plus Cold Medicine Sparkling Original10 in 1 CARTONTABLET, EFFERVESCENT109
0280-1400-20Alka-Seltzer Plus Cold Medicine Sparkling Original2 in 1 POUCHTABLET, EFFERVESCENT29
0280-1400-32Alka-Seltzer Plus Cold Medicine Sparkling Original2 in 1 POUCHTABLET, EFFERVESCENT29
0280-1400-32Alka-Seltzer Plus Cold Medicine Sparkling Original16 in 1 CARTONTABLET, EFFERVESCENT169
0280-1400-36Alka-Seltzer Plus Cold Medicine Sparkling Original18 in 1 CARTONTABLET, EFFERVESCENT189
0280-1400-36Alka-Seltzer Plus Cold Medicine Sparkling Original2 in 1 POUCHTABLET, EFFERVESCENT29
0280-1400-48Alka-Seltzer Plus Cold Medicine Sparkling Original24 in 1 CARTONTABLET, EFFERVESCENT249
0280-1400-48Alka-Seltzer Plus Cold Medicine Sparkling Original2 in 1 POUCHTABLET, EFFERVESCENT29
0280-1400-72Alka-Seltzer Plus Cold Medicine Sparkling Original2 in 1 POUCHTABLET, EFFERVESCENT29
0280-1400-72Alka-Seltzer Plus Cold Medicine Sparkling Original36 in 1 CARTONTABLET, EFFERVESCENT369

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-1400-36EA - Each0280-1400d9ce5ae8-6625-47f9-ad92-12f7edef8e0512018-12-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
PHENYLEPHRINE BITARTRATEACTIVE INGREDIENT27O3Q5ML57ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
ASPIRINACTIVE MOIETYR16CO5Y76EALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
CALCIUM SILICATEINACTIVE INGREDIENTS4255P4G5MALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-1400ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.]8Current NDC, Legacy NDC, 12 package rows20231205_78537dcf-b157-4b67-a8b2-5cb144815166.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 48 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mgASPIRINAsclemed USA, Inc.878dab20-668b-4d7a-a5f8-794a587564d52025-02-13WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCVS HEALTH CORPbbc48c9e-7eb8-2c67-e053-2a95a90a85522025-02-13WarningsExact identifier
application number: M013
Dye Free Infants Pain and FeverACETAMINOPHENCVS1fde0f7c-4b5b-ae9c-e063-6394a90afa412025-02-13WarningsExact identifier
application number: M013
NOTTS - Extra Strength 500 mgACETAMINOPHENVIVUNT PHARMA LLCe677f43d-b4ce-e5b0-e053-2a95a90ad67e2025-02-12WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINELEADER/ Cardinal Health 110, Inc.b3773f02-02a9-33c8-e053-2995a90a22352025-02-11WarningsExact identifier
application number: M013
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENTIME CAP LABORATORIES, INC.c9f80d24-bd05-e1ce-e053-2995a90aa6462025-02-10WarningsExact identifier
application number: M013
Low dose AspirinASPIRIN 81 MG DELAYED RELEASE TABLETSWALGREENSc25c55aa-9932-0a55-e053-2a95a90a3d1e2025-02-10WarningsExact identifier
application number: M013
AeroTab Pain RelieverPAIN RELIEVERAero Healthcare40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f2025-02-10WarningsExact identifier
application number: M013
Enteric Coated Aspirin Regular StrengthASPIRINTime-Cap Labs, Inc5fbd8bb3-46f9-4089-9a21-b6af97a061062025-02-08WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENTIME CAP LABS INCc193dbc0-cc80-4a7c-aa29-457a20edf8352025-02-08WarningsExact identifier
application number: M013
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.22f23aeb-f874-6e54-e063-6394a90a95652025-02-07WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3008928-c555-64ad-e053-2995a90a73072025-02-05WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINBETTER LIVING BRANDS LLC.f300dfbc-7137-79d1-e053-2995a90a636e2025-02-05WarningsExact identifier
application number: M013
Low dose aspirin 81mgASPIRINBETTER LIVING BRANDS LLC.f300c30b-ab1a-a1b4-e053-2a95a90a12942025-02-05WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC5d174187-cf89-41ff-9a64-10e0276daf172025-02-05WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENBryant Ranch Prepackc226205d-7c3c-49af-b3e2-fc7b09ad78572025-02-05WarningsExact identifier
application number: M013
Dye Free Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmaa69fca9d-c0a0-4321-bf03-5c8e99cc07cc2025-02-04WarningsExact identifier
application number: M013
TENSION HEADACHE RELIEFACETAMINOPHEN-CAFFEINETARGET CORPORATION8ed1679d-d3a1-11b1-e053-2995a90a61ad2025-01-31WarningsExact identifier
application number: M013
ValuMeds Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINECabinet Health P.B.C.0f864e73-e4b8-4e23-8990-8439ac17bd582025-01-31WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN TABLETS 500 MGWALGREENSc25bfe92-0196-0489-e053-2995a90abea12025-01-30WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536840aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletPSN78537dcf-b157-4b67-a8b2-5cb1448151669
1536840aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSCD78537dcf-b157-4b67-a8b2-5cb1448151669
1536840ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSY78537dcf-b157-4b67-a8b2-5cb1448151669

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-1400-12002801400122 in 1 POUCHHistorical
0280-1400-200028014002010 in 1 CARTONHistorical
0280-1400-320028014003216 POUCH in 1 CARTON (0280-1400-32) / 2 TABLET, EFFERVESCENT in 1 POUCH16 pouch2008-04-100000-00-00NoNoCurrent
0280-1400-360028014003618 in 1 CARTONHistorical
0280-1400-480028014004824 in 1 CARTONHistorical
0280-1400-72002801400722 in 1 POUCHHistorical