FDA.reportPublic FDA data

Soothe

Product NDC
0363-7240
11-digit product format
003637240
Labeler code
0363
Product ID
0363-7240_dfcc07cd-3ede-482a-bede-568d9a90979c
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Walgreens
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-29
Marketing end
2027-03-29
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Soothe

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308762

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-7240-082023-10-10C16284748780-1f386c64a-06f0-0266-e053-dadaa90a7c1aDrug Facts
0363-7240-162023-10-10C16284748780-1f386c64a-06f0-0266-e053-dadaa90a7c1aDrug Facts
0363-7240-082023-01-30C16284748780-1f386c64a-06f0-0266-e053-dadaa90a7c1aDrug Facts
0363-7240-162023-01-30C16284748780-1f386c64a-06f0-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-7240-08Soothe237 mL in 1 BOTTLE, PLASTICLIQUID2377
0363-7240-16Soothe473 mL in 1 BOTTLE, PLASTICLIQUID4737

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7240SOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]6Current NDC, Legacy NDC, 2 package rows20240627_394e16b8-dd7c-4c68-86ce-3623936745a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN394e16b8-dd7c-4c68-86ce-3623936745a77
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD394e16b8-dd7c-4c68-86ce-3623936745a77
308762bismuth subsalicylate 1.75 % Oral SuspensionSY394e16b8-dd7c-4c68-86ce-3623936745a77
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY394e16b8-dd7c-4c68-86ce-3623936745a77
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY394e16b8-dd7c-4c68-86ce-3623936745a77
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY394e16b8-dd7c-4c68-86ce-3623936745a77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-7240-0800363724008237 mL in 1 BOTTLE, PLASTIC (0363-7240-08) 237 ml2019-11-292027-03-29NoNoCurrent
0363-7240-1600363724016473 mL in 1 BOTTLE, PLASTIC (0363-7240-16) 473 ml2019-11-292027-03-29NoNoCurrent