FDA.reportPublic FDA data

Soothe

Product NDC
0363-5960
11-digit product format
003635960
Labeler code
0363
Product ID
0363-5960_cd0bb2db-032c-4ab9-913f-23135b5add64
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Walgreen Company
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-01
Substance
CALCIUM CARBONATE
Active strength
400 mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Soothe
Brand name suffix
childrens
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H0G9379FGKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
317865Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0235e083-5f3d-4bae-b14a-b12db623180cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5960-08Soothechildrens24 in 1 BOTTLE, PLASTICTABLET, CHEWABLE2416
0363-5960-08Soothechildrens1 in 1 CARTONTABLET, CHEWABLE116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5960SOOTHE CHILDRENS (CALCIUM CARBONATE) TABLET, CHEWABLE [WALGREEN COMPANY]15Current NDC, Legacy NDC, 2 package rows20250315_0235e083-5f3d-4bae-b14a-b12db623180c.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 1 of 37 · 739 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Sana Lemon Alivio Digestivo UPSET STOMACHEFFERVESCENT ANTACIDEVI LABS59cdf417-e5c0-6bb2-e063-6294a90a9c512026-08-24WarningsExact identifier
application number: M001
Dr Sana Alivio Digestivo Naranja UPSET STOMACHEFFERVESCENT ANTACIDEVI LABS59d07c2d-ef11-bd32-e063-6394a90af87d2026-08-24WarningsExact identifier
application number: M001
Genexa Antacid Maximum StrengthCALCIUM CARBONATEGenexa Inc.3a39d91c-2dcd-71d6-e063-6394a90a54742026-08-22WarningsExact identifier
application number: M001
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
application number: M001
CVS Health Extra Strength AntacidALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS PHARMACY8629529e-4363-4d37-9ae0-27193868df322026-08-19WarningsExact identifier
application number: M001
CVS NaturalsCALCIUM CARBONATECVS PHARMACY899f057a-914d-49ca-a9fd-9fc48149782a2026-08-14WarningsExact identifier
application number: M001
CVS Health Extra Strength Heartburn Relief Antacid Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS Pharmacy,Inc.5c32d90b-68a0-4acf-94b6-d02037cea3762026-08-13WarningsExact identifier
application number: M001
Extra Strength SmoothANTACID TABLETSCVSc00204f7-c343-4451-9e0f-638ebb72f07c2026-08-13WarningsExact identifier
application number: M001
CVS PHARMACY Extra Strength Cherry FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS Pharmacy,Inc.cf7ae053-fa8d-4e6e-af4f-b846699aaf242026-08-13WarningsExact identifier
application number: M001
CVS Extra Strength SmoothCALCIUM CARBONATECVS PHARMACY70752251-02fe-4639-a4a8-afef32463c322026-08-13WarningsExact identifier
application number: M001
CVS PHARMACY,INC. Assorted BerryANTACID TABLETSCVS PHARMACY,INC.19f0847e-1512-465c-b67f-d61ef4a16cfa2026-08-12WarningsExact identifier
application number: M001
CVS PHARMACY Assorted Berry AntacidCALCIUM CARBONATECVS7f0a4d88-4e3c-448e-90b1-ae03966b78062026-08-12WarningsExact identifier
application number: M001
Extra StrengthANTACID TABLETSCVS PHARMACYf3cd6627-cd82-4d39-9593-55f016c72eec2026-08-12WarningsExact identifier
application number: M001
CVS Health Extra Strength Sugar FreeANTACIDCVS PHARMACY, INC.49e23561-d392-415c-9e6f-2dbcf64c96362026-08-12WarningsExact identifier
application number: M001
CVS PHARMACY Assorted Fruit AntacidCALCIUM CARBONATECVS8ab371eb-9839-47f0-b576-d917f69ed16d2026-08-12WarningsExact identifier
application number: M001
CVS Ultra StrengthANTACID TABLETSCVS6108271a-4336-4f90-9765-9c3aea1094882026-08-12WarningsExact identifier
application number: M001
CVS PHARMACY,INC. Assorted FruitANTACID TABLETSCVS PHARMACY,INC.60294e90-4b9c-4419-876c-3da037d76cfd2026-08-12WarningsExact identifier
application number: M001
Whole Foods Market Regular Strength Peppermint FlavorCALCIUM CARBONATEWHOLE FOODS MARKET, INC.4cdf0cd0-f69f-4f86-a9ff-cda5cb002d652026-08-11WarningsExact identifier
application number: M001
Whole Foods Market Regular Strength Peppermint FlavorCALCIUM CARBONATEWHOLE FOODS MARKET, INC.ec3f0e47-52f3-4ffd-a3d3-71ef4bd11f082026-08-11WarningsExact identifier
application number: M001
Whole Foods Market Regular Strength Peppermint FlavorCALCIUM CARBONATEWHOLE FOODS MARKET, INC.639665ca-476e-4fbf-9378-a08cb28c15f62026-08-11WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317865calcium carbonate 400 MG (Ca 170 MG) Chewable TabletPSN0235e083-5f3d-4bae-b14a-b12db623180c16
317865calcium carbonate 400 MG Chewable TabletSCD0235e083-5f3d-4bae-b14a-b12db623180c16
317865calcium carbonate 400 MG (as calcium 161 MG) Chewable TabletSY0235e083-5f3d-4bae-b14a-b12db623180c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-5960-08003635960081 BOTTLE, PLASTIC in 1 CARTON (0363-5960-08) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2018-08-010000-00-00NoNoCurrent