FDA.reportPublic FDA data

Medique Medi Seltzer

Product NDC
47682-135
11-digit product format
476820135
Labeler code
47682
Product ID
47682-135_3cb9b823-c883-264e-e063-6294a90a008b
Type
HUMAN OTC DRUG
Nonproprietary name
aspirin, citric acid, sodium bicarbonate
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-12-30
Marketing end
2027-01-01
Substance
ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE
Active strength
325; 1000; 1916 mg/1; mg/1; mg/1
Pharmacologic classes
Acidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

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
Medique Medi Seltzer

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1
CITRIC ACID MONOHYDRATE1000 mg/1
SODIUM BICARBONATE1916 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
2968PHW8QPInternal UNII lookup
8MDF5V39QOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1536675Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
528da9d9-2a52-4c16-b7b2-61b3eee1abeaAvailable on FDA.report

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
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
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
47682-135-20Medique Medi Seltzer2 in 1 PACKETTABLET, EFFERVESCENT213
47682-135-20Medique Medi Seltzer18 in 1 BOXTABLET, EFFERVESCENT1813
47682-135-24Medique Medi Seltzer2 in 1 PACKETTABLET, EFFERVESCENT213
47682-135-24Medique Medi Seltzer36 in 1 BOXTABLET, EFFERVESCENT3613
47682-135-60Medique Medi Seltzer300 in 1 BOXTABLET, EFFERVESCENT30013
47682-135-60Medique Medi Seltzer2 in 1 PACKETTABLET, EFFERVESCENT213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47682-135-20EA - Each47682-1353a60a112-cf81-480a-9d36-2eefc393a43812012-07-24
47682-135-24EA - Each47682-135073ac5ec-1b07-489e-bd2c-b152e5a9ce6a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EMEDIQUE MEDI SELTZER (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [UNIFIRST FIRST AID CORPORATION]4
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QPMEDIQUE MEDI SELTZER (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [UNIFIRST FIRST AID CORPORATION]4
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOMEDIQUE MEDI SELTZER (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [UNIFIRST FIRST AID CORPORATION]4
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLMEDIQUE MEDI SELTZER (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [UNIFIRST FIRST AID CORPORATION]4
ASPIRINACTIVE MOIETYR16CO5Y76EMEDIQUE MEDI SELTZER (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [UNIFIRST FIRST AID CORPORATION]4
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q20MEDIQUE MEDI SELTZER (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [UNIFIRST FIRST AID CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-135MEDIQUE MEDI SELTZER (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [UNIFIRST FIRST AID CORPORATION]12Current NDC, Legacy NDC, 6 package rows20241120_528da9d9-2a52-4c16-b7b2-61b3eee1abea.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 70 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN, AND CAFFEINEJHK Inc dba American Safety & First Aid87c5ad71-0448-4e0f-acee-bf9a1d38675e2024-04-25WarningsExact identifier
application number: M013
dg health childrens pain and feverACETAMINOPHENDolgencorp Inc49b2ac72-86a3-4783-bf51-8c1a222e457e2024-04-25WarningsExact identifier
application number: M013
basic care infants pain and feverACETAMINOPHENAmazon.com Services LLCdab1f9e6-3875-4d53-a417-c6a78274ee562024-04-23WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLCa71074a6-cc19-4bb3-8c84-4e82a89068012024-04-22WarningsExact identifier
application number: M013
Regular Strength AcetaminophenACETAMINOPHENKROGER COMPANY0fe995cd-f974-db04-e063-6294a90a33552024-04-18WarningsExact identifier
application number: M013
Regular Strength Aspirin 325 mgASPIRINKroger0fc3193d-af4e-ff3a-e063-6294a90a27432024-04-17WarningsExact identifier
application number: M013
Childrens Pain and Fever Dye FreeACETAMINOPHENKROGER COMPANY0fec66b4-3a2a-63d1-e063-6294a90a6d722024-04-17WarningsExact identifier
application number: M013
aspirin low dose chewableASPIRINTime-Cap Labs, Inc5d56618c-8ea2-42ea-a9f2-339bd0055ddd2024-04-17WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINP & L Development, LLC0058175f-3474-40c3-a046-6cfaec86d84b2024-04-16WarningsExact identifier
application number: M013
Handy Solutions Headache Pain ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENavajo Manufacturing Company Inc.e5481abe-6971-2bc5-e053-2995a90ae8952024-04-15WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENMajor Pharmaceuticals243a5cff-e506-434b-ab19-1a6ac53f85332024-04-15WarningsExact identifier
application number: M013
Dye Free Pain Reliever ChildrensACETAMINOPHENP & L Development, LLC45ddcaad-d416-4d7c-a84a-43548d5c5d3b2024-04-15WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.65bf1556-f25a-9439-e053-2a91aa0a31942024-04-15WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybbeebdd6-fe2c-5b8a-e053-2a95a90ab95e2024-04-13WarningsExact identifier
application number: M013
infants pain reliefACETAMINOPHENPublix Super Markets Inc3d1818a7-d3b2-434c-b3c9-b2713f08ded22024-04-13WarningsExact identifier
application number: M013
Mommys Bliss Childrens Pain and FeverACETAMINOPHENMom Enterprises, LLC.08b9eaf7-70d1-640f-e063-6394a90a8d3b2024-04-12WarningsExact identifier
application number: M013
Mommys Bliss Infants Pain and FeverACETAMINOPHENMom Enterprises, LLC.05e26650-81b3-d7b1-e063-6394a90a14ed2024-04-11WarningsExact identifier
application number: M013
Childrens Pain ReliefCHILDRENS PAIN RELIEFAllegiant Health7381dd26-c507-4d02-b989-cfd96e02f4952024-04-11WarningsExact identifier
application number: M013
Childrens Pain Relief Dye-FreeACTEAMINOPHENWinCo Foods, LLC5ee134b3-b8e9-4621-b0a1-a84d9867ccba2024-04-11WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENWALGREENS0b1d086f-7be1-5072-e063-6394a90a11e62024-04-10WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletPSN528da9d9-2a52-4c16-b7b2-61b3eee1abea13
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD528da9d9-2a52-4c16-b7b2-61b3eee1abea13
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY528da9d9-2a52-4c16-b7b2-61b3eee1abea13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-135-204768201352018 PACKET in 1 BOX (47682-135-20) / 2 TABLET, EFFERVESCENT in 1 PACKET18 packet2008-12-302027-01-01NoNoCurrent
47682-135-244768201352436 PACKET in 1 BOX (47682-135-24) / 2 TABLET, EFFERVESCENT in 1 PACKET36 packet2008-12-302027-01-01NoNoCurrent
47682-135-6047682013560300 PACKET in 1 BOX (47682-135-60) / 2 TABLET, EFFERVESCENT in 1 PACKET300 packet2008-12-302027-01-01NoNoCurrent