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 6 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECARDINAL HEALTH 110, LLC. DBA LEADER7d6047a9-5557-487a-ae06-f904dac626c92025-10-14WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEAtlantic Biologicals Corp401f8393-680c-e1a8-e063-6394a90a81ab2025-10-01WarningsExact identifier
application number: M008
First Aid Direct Peptum TabsBISMUTH SUBSALICYLATECintas Corpdd14cd57-3f7c-4634-9da9-6f83dc5bae122025-09-29WarningsExact identifier
application number: M008
RIGHT REMEDIES Stomach Relief BISMUTH SUBSALICYLATE 262 mg softgelBISMUTH SUBSALICYLATEStrive Pharmaceuticals Inc.0f271054-fa96-4475-8279-65f4565aba362025-09-22WarningsExact identifier
application number: M008
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEFSA Store Inc. (Caring Mill)fbabc313-600a-4722-9948-1a3e214140592025-09-18WarningsExact identifier
application number: M008
QUALITY CHOICE ULTRA STRENGTH STOMACH RELIEFBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)67c610b1-fe94-4ad3-ad1a-8bd93a4da9d92025-09-11WarningsExact identifier
application number: M008
Medique DiotameBISMUTH SUBSALICYLATEUnifirst First Aid Corporation0667ec26-c2cd-153c-e054-00144ff88e882025-09-08WarningsExact identifier
application number: M008
McKesson BismuthBISMUTH SUBSALICYLATEMcKesson Medical-Surgicald1f3dfa4-e021-6384-e053-2995a90a7b422025-09-08WarningsExact identifier
application number: M008
Medi-First Pep-T-MedBISMUTH SUBSALICYLATEUnifirst First Aid Corporation88f4d5d4-92ed-40ab-97a9-181da72f869b2025-09-08WarningsExact identifier
application number: M008
Thompson Chewable Bismuth TabsBISMUTH SUBSALICYLATEThompson Safety LLCc94b9bc2-b764-a9a7-e053-2a95a90aed812025-09-08WarningsExact identifier
application number: M008
Goodsense Regular strength Stomach Relief 122BISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.f0588ab8-d1fc-419a-8d68-bee42332d50f2025-08-01WarningsExact identifier
application number: M008
Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATE 525 MGRetail Business Services, LLC.338ca589-91ff-30ed-e063-6294a90a243a2025-07-21WarningsExact identifier
application number: M008
Regular Strength Stomach ReliefBISMUTH SUBSALICYLATE 525 MGRetail Business Services, LLC.338d61af-35a8-fba7-e063-6294a90a38e82025-07-21WarningsExact identifier
application number: M008
SennaSENNOSIDESMajor Pharmaceuticalscfb6bf89-c77e-4372-9bc9-44d6a659c9552025-07-18WarningsExact identifier
application number: M008
Major Bismuth SubsalicylateBISMUTH SUBSALICYLATEMajor Pharmaceuticals2a7c9cc1-206e-4018-b89d-7b634df43df62025-07-11WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55440401-f82f-45a3-ba7e-6ccdfdacead32025-07-10WarningsExact identifier
application number: M008
Upset Stomach Relief-Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATE 262 MGPioneer Life Sciences, LLC07e2cc82-ab0e-46c5-863b-67658b6126782025-06-27WarningsExact identifier
application number: M008
Upset Stomach Relief-Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATE 262 MGNUVICARE LLC6697e464-00ac-41de-a7ea-d7bb24ed5e2a2025-06-25WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEP & L Development, LLC8383945f-b3a7-4242-bfaa-acf24b66406d2025-05-30WarningsExact identifier
application number: M008
5-Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION28fba615-48ca-8d96-e063-6394a90a27972025-04-12WarningsExact 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