SIGNATURE CARE

Product NDC
21130-182
11-digit product format
211300182
Labeler code
21130
Product ID
21130-182_b4643d99-90ce-4f00-a61a-a5371fe0f424
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
SUSPENSION
Route
ORAL
Labeler
SAFEWAY
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-02
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

Additional Listing Data#

Finished product
Yes
Brand name base
SIGNATURE CARE
Brand name suffix
Regular Strength
Listing expiration
2027-12-31

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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-182-12SIGNATURE CARERegular Strength354 mL in 1 BOTTLESUSPENSION3541
21130-182-16SIGNATURE CARERegular Strength473 mL in 1 BOTTLESUSPENSION4731

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSNb4643d99-90ce-4f00-a61a-a5371fe0f4241
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCDb4643d99-90ce-4f00-a61a-a5371fe0f4241
308762bismuth subsalicylate 1.75 % Oral SuspensionSYb4643d99-90ce-4f00-a61a-a5371fe0f4241
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSYb4643d99-90ce-4f00-a61a-a5371fe0f4241
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSYb4643d99-90ce-4f00-a61a-a5371fe0f4241
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSYb4643d99-90ce-4f00-a61a-a5371fe0f4241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-182-1221130018212354 mL in 1 BOTTLE (21130-182-12) 354 ml2026-02-02NoNoCurrent
21130-182-1621130018216473 mL in 1 BOTTLE (21130-182-16) 473 ml2026-02-02NoNoCurrent