FDA.reportPublic FDA data

Signature Care Effervescent Antacid and Pain Relief

Product NDC
21130-421
11-digit product format
211300421
Labeler code
21130
Product ID
21130-421_26d0e69e-9dcd-dc00-e063-6394a90a344a
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin, Citric Acid, Sodium Bicarbonate
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Safeway, Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-12
Marketing end
2026-12-31
Substance
SODIUM BICARBONATE; ANHYDROUS CITRIC ACID; ASPIRIN
Active strength
1916; 1000; 325 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
Signature Care Effervescent Antacid and Pain Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM BICARBONATE1916 mg/1
ANHYDROUS CITRIC ACID1000 mg/1
ASPIRIN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8MDF5V39QOInternal UNII lookup
XF417D3PSLInternal UNII lookup
R16CO5Y76EInternal 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
6e120024-475a-73af-e053-2a91aa0a42a6Available 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
21130-421-68Signature Care Effervescent Antacid and Pain Relief2 in 1 POUCHTABLET, EFFERVESCENT25
21130-421-68Signature Care Effervescent Antacid and Pain Relief18 in 1 CARTONTABLET, EFFERVESCENT185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-421SIGNATURE CARE EFFERVESCENT ANTACID AND PAIN RELIEF (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SAFEWAY, INC]5Current NDC, Legacy NDC, 2 package rows20241212_6e120024-475a-73af-e053-2a91aa0a42a6.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 57 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aspirinASPIRINA-S Medication Solutions65c41c20-2f9c-4012-900b-c2ffdf6651442024-11-06WarningsExact identifier
application number: M013
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLC338021bd-b92b-45eb-a4b8-bc4a100ab7182024-11-06WarningsExact identifier
application number: M013
basic care headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmazon.com Services LLCf85d2f4c-8184-4555-a310-3979722e860b2024-11-05WarningsExact identifier
application number: M013
MENSTRUAL COMPLETEMENSTRUAL COMPLETEAllegiant Healthd197b886-67e4-4aba-8582-305576c076042024-11-05WarningsExact identifier
application number: M013
dg health headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp Incddf40cc4-d73f-4460-be72-9486134329a72024-11-05WarningsExact identifier
application number: M013
DOLO- NeuroBion Acetaminophen 500mgACETAMINOPHENBENARD INDUSTRIES INC16f8415d-8190-4212-b487-c0caf7d3bee22024-11-04WarningsExact identifier
application number: M013
basic care acetaminophenACETAMINOPHENAmazon.com Services LLC8c3343ee-d7b6-496d-9702-6736539a72702024-11-02WarningsExact identifier
application number: M013
dg health pain reliefACETAMINOPHENDolgencorp, LLC382fa2cc-1c39-4bee-b528-08b11ec945af2024-11-02WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENBryant Ranch Prepackf7e20527-1d4b-434c-997b-3eb8211fdaa12024-11-01WarningsExact identifier
application number: M013
Aspirin Enteric Safety CoatedASPIRINPublix Supermarkets, Inc.a661a9ed-9b31-46b1-aafb-61d1ba8a49182024-11-01WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENBryant Ranch Prepack614e69c7-d3cb-4d47-9603-c1c14b87544c2024-11-01WarningsExact identifier
application number: M013
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporationbaee03b8-fcfd-440e-90ea-1ee2a18516ef2024-11-01WarningsExact identifier
application number: M013
good neighbor pharmacy infants pain and feverACETAMINOPHENAmerisource Bergenbfb954b7-3a79-4bca-95e8-d39e1074b07f2024-11-01WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEVERACETAMINOPHEN, ASPIRIN AND CAFFEINEProficient Rx LPbf365bfc-35cc-47f9-a50b-ff2b38d7316b2024-11-01WarningsExact identifier
application number: M013
Infants Pain ReliefACETAMINOPHENPublix Super Markets Inc0bc33897-afc2-4d11-be6c-a26480f448bf2024-10-31WarningsExact identifier
application number: M013
equate infants pain and feverACETAMINOPHENWALMART INC.34b2512e-743b-45db-92cb-ea05e2f47b3d2024-10-31WarningsExact identifier
application number: M013
foster and thrive infants pain and feverACETAMINOPHENStrategic Sourcing Services LLC45770ad6-9bf7-41bd-a724-e5260cd31fa12024-10-31WarningsExact identifier
application number: M013
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLETLil' Drug Store Products, Inc.d20425a4-f074-4154-e053-2995a90ae9fd2024-10-30WarningsExact identifier
application number: M013
up and up infants acetaminophenACETAMINOPHENTarget Corporation31104956-04d7-41b5-82be-219ded5c02a92024-10-30WarningsExact identifier
application number: M013
Sunmark AspirinASPIRINStrategic Sourcing Services LLCa7139686-b351-47dc-a395-832429aaa5692024-10-30WarningsExact 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 TabletPSN6e120024-475a-73af-e053-2a91aa0a42a65
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD6e120024-475a-73af-e053-2a91aa0a42a65
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY6e120024-475a-73af-e053-2a91aa0a42a65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-421-682113004216818 POUCH in 1 CARTON (21130-421-68) / 2 TABLET, EFFERVESCENT in 1 POUCH18 pouch2015-06-122026-12-31NoNoCurrent