FDA.reportPublic FDA data

POCKET PEPTO Pepto Bismol

Product NDC
58933-017
11-digit product format
589330017
Labeler code
58933
Product ID
58933-017_4e79fd8b-51db-d550-e063-6294a90a3637
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
Procter & Gamble Manufactura S de RL de CV
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-01
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
POCKET PEPTO Pepto Bismol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308760

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-017-12POCKET PEPTO Pepto Bismol12 in 1 VIAL, PLASTICTABLET127
58933-017-12POCKET PEPTO Pepto Bismol1 in 1 CARTONTABLET17
58933-017-24POCKET PEPTO Pepto Bismol2 in 1 CARTONTABLET27
58933-017-24POCKET PEPTO Pepto Bismol12 in 1 VIAL, PLASTICTABLET127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-017POCKET PEPTO PEPTO BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURA S DE RL DE CV]5Current NDC, 4 package rows20241012_0429d816-f3a9-2076-e063-6394a90aef21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN0429d816-f3a9-2076-e063-6394a90aef217
308760bismuth subsalicylate 262 MG Oral TabletSCD0429d816-f3a9-2076-e063-6394a90aef217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58933-017-12589330017121 VIAL, PLASTIC in 1 CARTON (58933-017-12) / 12 TABLET in 1 VIAL, PLASTIC2019-06-01NoNoHistorical
58933-017-24589330017242 VIAL, PLASTIC in 1 CARTON (58933-017-24) / 12 TABLET in 1 VIAL, PLASTIC2019-06-01NoNoHistorical