Pepto-Bismol

Product NDC
37000-440
11-digit product format
370000440
Labeler code
37000
Product ID
37000-440_4cd8234a-041b-a9e9-e063-6394a90ac431
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
SUSPENSION
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-03-01
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/15mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pepto-Bismol
Brand name suffix
Ultra
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/15mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-440-04Pepto-BismolUltra118 mL in 1 BOTTLE, PLASTICSUSPENSION11812
37000-440-08Pepto-BismolUltra236 mL in 1 BOTTLE, PLASTICSUSPENSION23612
37000-440-12Pepto-BismolUltra354 mL in 1 BOTTLE, PLASTICSUSPENSION35412
37000-440-36Pepto-BismolUltra354 mL in 1 BOTTLE, PLASTICSUSPENSION35412
37000-440-36Pepto-BismolUltra3 in 1 CELLO PACKSUSPENSION312

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-440PEPTO-BISMOL ULTRA (BISMUTH SUBSALICYLATE) SUSPENSION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Current NDC, Legacy NDC, 5 package rows20241012_673893bd-f8e9-23b0-e053-2a91aa0aa1d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN673893bd-f8e9-23b0-e053-2a91aa0aa1d412
211915Pepto-Bismol Max Strength 1050 MG in 30 mL Oral SuspensionPSN673893bd-f8e9-23b0-e053-2a91aa0aa1d412
211915bismuth subsalicylate 35 MG/ML Oral Suspension [Pepto-bismol]SBD673893bd-f8e9-23b0-e053-2a91aa0aa1d412
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD673893bd-f8e9-23b0-e053-2a91aa0aa1d412
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY673893bd-f8e9-23b0-e053-2a91aa0aa1d412
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY673893bd-f8e9-23b0-e053-2a91aa0aa1d412
211915Pepto-bismol 35 MG/ML Oral SuspensionSY673893bd-f8e9-23b0-e053-2a91aa0aa1d412
211915Pepto-bismol 525 MG per 15 ML Oral SuspensionSY673893bd-f8e9-23b0-e053-2a91aa0aa1d412
211915Pepto-bismol Max Strength 1050 MG per 30 ML Oral SuspensionSY673893bd-f8e9-23b0-e053-2a91aa0aa1d412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-440-0437000044004118 mL in 1 BOTTLE, PLASTIC (37000-440-04) 118 ml2018-03-010000-00-00NoNoCurrent
37000-440-0837000044008236 mL in 1 BOTTLE, PLASTIC (37000-440-08) 236 ml2018-03-010000-00-00NoNoCurrent
37000-440-1237000044012354 mL in 1 BOTTLE, PLASTIC (37000-440-12) 354 ml2018-03-010000-00-00NoNoCurrent
37000-440-36370000440363 BOTTLE, PLASTIC in 1 CELLO PACK (37000-440-36) / 354 mL in 1 BOTTLE, PLASTIC2024-07-01NoNoCurrent