FDA.reportPublic FDA data

Soothe

Product NDC
0363-0073
11-digit product format
003630073
Labeler code
0363
Product ID
0363-0073_8451f30d-bd04-44e4-b0c1-29d9b04ecadc
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Walgreens
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-31
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Soothe
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62TEY51RR1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308762Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2b2b0ce-034e-4857-bfca-0087bb31878eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0073-08Soothe237 mL in 1 BOTTLE, PLASTICLIQUID2376
0363-0073-16Soothe473 mL in 1 BOTTLE, PLASTICLIQUID4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0073-08ML - Milliliter0363-0073d3e745d2-731b-47cb-9842-0875d425495b12022-06-06
0363-0073-16ML - Milliliter0363-0073282791b9-15f8-4fb7-b333-35d74b923da212022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1SOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMSOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]2
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RTSOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHSOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]2
METHYLCELLULOSE (1500 MPA.S)INACTIVE INGREDIENTP0NTE48364SOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]2
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZSOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]2
SODIUM SALICYLATEINACTIVE INGREDIENTWIQ1H85SYPSOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BSOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]2
WATERINACTIVE INGREDIENT059QF0KO0RSOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0073SOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]6Current NDC, Legacy NDC, 2 package rows20240726_a2b2b0ce-034e-4857-bfca-0087bb31878e.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 3 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KaopectateBISMUTH SUBSALICYLATEKramer Laboratories3877a88d-9546-48ce-ad6b-3c2a115e3eaf2026-06-03WarningsExact identifier
application number: M008
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.f0976d6c-d574-49e8-b98a-23a660d83fa02026-06-02WarningsExact identifier
application number: M008
Stomach Relief Maximum StrengthBISMUTH SUBSALICYLATECVS Pharmacy9d8f2456-732d-40bf-a10c-98423560c0292026-05-13WarningsExact identifier
application number: M008
Green Guard Instydose Upset Stomach ReliefBISMUTH SUBSALICYLATEUnifirst First Aid Corporation5b1f31a9-8eec-4c3d-e063-6394a90a2efe2026-05-01WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)6f189c12-eb94-476e-a8f7-ea82f44c4aa52026-04-13WarningsExact identifier
application number: M008
Pepto BismolBISMUTH SUBSALICYLATENavajo Manufacturing Company Inc.033bccc6-6e81-487f-91fe-9d7cc465e1b22026-04-08WarningsExact identifier
application number: M008
SootheBISMUTH SUBSALICYLATEWalgreens450483c3-487f-4a8f-a439-5661241a8f0f2026-04-08WarningsExact identifier
application number: M008
GS Stomach ReliefBISMUTH SUBSALICYLATE 525 MGGood Sense (Geiss, Destin & Dunn, Inc.)edd15c7d-f66b-4b1a-8cda-9814a37904832026-03-31WarningsExact identifier
application number: M008
WALGREEN ULTRA STRENGTH PINK BISMUTHBISMUTH SUBSALICYLATEWALGREENS CO.d0f78754-2556-4aa8-949b-a6e3b4adf8c22026-03-25WarningsExact identifier
application number: M008
Dr. Simi Stomach ReliefBISMUTH SUBSALICYLATE 525 MGFarmacias De Similares TX LLC4dc9233e-68fb-e1e8-e063-6294a90aee332026-03-24WarningsExact identifier
application number: M008
Major Bismuth SubsalicylateBISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.69b9999f-c2e5-43a6-891f-0e24d3c343a42026-03-20WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEGrocery Outlet, Inc.4465dd17-c333-7b95-e063-6294a90a50532026-03-19WarningsExact identifier
application number: M008
AMAZON Regular StrengthBISMUTH SUBSALICYLATEAMAZON.COM SERVICES LLC6b41f36d-1810-45f7-a46c-67b9bff237382026-03-04WarningsExact identifier
application number: M008
AMAZON Digestive ReliefBISMUTH SUBSALICYLATEAMAZON.COM SERVICES LLCa9a676d8-06b9-43bf-9c06-08670c9ab2112026-03-04WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEWal-Mart Stores Inc2d7d563e-4c46-4788-b6a7-5b92e3d585332026-02-26WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEChain Drug Marketing Association, Inc.d63110ee-2d64-46dd-80bf-696c9b9d8d7c2026-02-26WarningsExact identifier
application number: M008
SIGNATURE CARE Ultra Strength StomachBISMUTH SUBSALICYLATESAFEWAY4b54fa21-d8ea-4497-aa32-17e47669c8e12026-02-20WarningsExact identifier
application number: M008
SIGNATURE CARE Regular StrengthBISMUTH SUBSALICYLATESAFEWAYb4643d99-90ce-4f00-a61a-a5371fe0f4242026-02-20WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEGrocery Outlet, Inc.44673b4f-1bf8-9db3-e063-6294a90a62f52026-02-14WarningsExact identifier
application number: M008
Treda UltraBISMUTH SUBSALICYLATELaboratorios Sanfer, S.A. de C.V.cfa7f37a-e18b-4929-b3a4-4126b0aa679a2026-02-12WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSNa2b2b0ce-034e-4857-bfca-0087bb31878e6
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCDa2b2b0ce-034e-4857-bfca-0087bb31878e6
308762bismuth subsalicylate 1.75 % Oral SuspensionSYa2b2b0ce-034e-4857-bfca-0087bb31878e6
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSYa2b2b0ce-034e-4857-bfca-0087bb31878e6
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSYa2b2b0ce-034e-4857-bfca-0087bb31878e6
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSYa2b2b0ce-034e-4857-bfca-0087bb31878e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0073-0800363007308237 mL in 1 BOTTLE, PLASTIC (0363-0073-08) 237 ml2015-01-310000-00-00NoNoCurrent
0363-0073-1600363007316473 mL in 1 BOTTLE, PLASTIC (0363-0073-16) 473 ml2015-01-310000-00-00NoNoCurrent