FDA.reportPublic FDA data

Alka-Seltzer Original Flavor

Product NDC
0280-0087
11-digit product format
002800087
Labeler code
0280
Product ID
0280-0087_452648e2-82a6-84f5-e063-6394a90a6df1
Type
HUMAN OTC DRUG
Nonproprietary name
Alka-Seltzer Original Flavor
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-03
Substance
ASPIRIN
Active strength
325 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alka-Seltzer Original Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui2606079

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0087-01Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-01Alka-Seltzer Original Flavor6 in 1 CARTONTABLET, EFFERVESCENT610
0280-0087-02Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-02Alka-Seltzer Original Flavor18 in 1 CARTONTABLET, EFFERVESCENT1810
0280-0087-03Alka-Seltzer Original Flavor36 in 1 CARTONTABLET, EFFERVESCENT3610
0280-0087-03Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-04Alka-Seltzer Original Flavor12 in 1 CARTONTABLET, EFFERVESCENT1210
0280-0087-04Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-06Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-06Alka-Seltzer Original Flavor58 in 1 CARTONTABLET, EFFERVESCENT5810

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANHYDROUS CITRIC ACIDACTIVE INGREDIENTXF417D3PSLALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
ASPIRINACTIVE MOIETYR16CO5Y76EALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37ALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUALKA-SELTZER LEMON LIME TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0087ALKA-SELTZER ORIGINAL FLAVOR TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.]9Current NDC, Legacy NDC, 10 package rows20241208_07478020-5ba0-3b67-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2606079aspirin 325 MG Effervescent Oral TabletPSN07478020-5ba0-3b67-e054-00144ff88e8810
2606079aspirin 325 MG Effervescent Oral TabletSCD07478020-5ba0-3b67-e054-00144ff88e8810
2606079ASA 325 MG Effervescent Oral TabletSY07478020-5ba0-3b67-e054-00144ff88e8810
2606079aspirin 325 MG Effervescent Oral TabletPSNf70875ab-241c-4876-e053-6294a90a80922
2606079aspirin 325 MG Effervescent Oral TabletSCDf70875ab-241c-4876-e053-6294a90a80922
2606079ASA 325 MG Effervescent Oral TabletSYf70875ab-241c-4876-e053-6294a90a80922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-0087-01002800087016 POUCH in 1 CARTON (0280-0087-01) / 2 TABLET, EFFERVESCENT in 1 POUCH6 pouch2023-04-18NoNoHistorical
0280-0087-020028000870218 POUCH in 1 CARTON (0280-0087-02) / 2 TABLET, EFFERVESCENT in 1 POUCH18 pouch2022-03-030000-00-00NoNoCurrent
0280-0087-030028000870336 POUCH in 1 CARTON (0280-0087-03) / 2 TABLET, EFFERVESCENT in 1 POUCH36 pouch2022-04-040000-00-00NoNoCurrent
0280-0087-040028000870412 POUCH in 1 CARTON (0280-0087-04) / 2 TABLET, EFFERVESCENT in 1 POUCH12 pouch2022-03-030000-00-00NoNoCurrent
0280-0087-060028000870658 POUCH in 1 CARTON (0280-0087-06) / 2 TABLET, EFFERVESCENT in 1 POUCH58 pouch2023-04-26NoNoHistorical