Over-the-counter drug · OTC MONOGRAPH DRUG

Pink-Bismuth (Bismuth subsalicylate) NDC 53041-527

Bismuth subsalicylate 262 mg/15mL · Liquid · Oral · Guardian Drug Company

NDC codes

FDA NDC Directory
Product NDC (as listed)53041-527Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53041-0527Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
53041-527-035304105270353041052703118 mL in 1 BOTTLE (53041-527-03)Marketed from May 30, 2008
53041-527-045304105270453041052704236 mL in 1 BOTTLE (53041-527-04)Marketed from May 30, 2008
53041-527-055304105270553041052705354 mL in 1 BOTTLE (53041-527-05)Marketed from May 30, 2008
53041-527-065304105270653041052706473 mL in 1 BOTTLE (53041-527-06)Marketed from May 30, 2008

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Pink-Bismuth
Generic name (nonproprietary)
bismuth subsalicylate
Active ingredients
Bismuth subsalicylate — 262 mg/15mL
Dosage form
Liquid
Route
Oral
Labeler
Guardian Drug CompanyNDC labeler code 53041
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 008
Marketing start
Listing expires
Other FDA classes
Bismuth (Chemical structure)
Identifiers
Product ID 53041-527_13b52b6e-d8cb-476e-a8af-e6df6d02b22fSPL ID 13b52b6e-d8cb-476e-a8af-e6df6d02b22fSPL set ID cb7da2b4-5e44-488b-a6e7-362e9b06c49cRxCUI 308762UNII 62TEY51RR1
Pharmacologic class
Bismuth

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N453041052703 followed by a unit qualifier and the quantity

Package 53041-0527-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Uses relieves: diarrhea heartburn indigestion nausea upset stomach associated with these symptoms

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53041-527

What is NDC 53041-527?
53041-527 is the product NDC for Pink-Bismuth (bismuth subsalicylate), Bismuth subsalicylate 262 mg/15mL liquid, listed with the FDA by Guardian Drug Company. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pink-Bismuth (Bismuth Subsalicylate).
What is the active ingredient?
Bismuth subsalicylate.
Who is the labeler?
Guardian Drug Company, NDC labeler code 53041. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pink-Bismuth?
1 other product NDC are listed under this name. See all Pink-Bismuth NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pink-Bismuth NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pink Bismuthbismuth subsalicylateBismuth subsalicylate 262 mg/1Tablet, ChewableOralDiscount Drug Mart, Inc53943-12253943-0122-35

Other NDCs under M 008

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 008
ProductStrengthForm · routeLabelerProduct NDC
RITE AID Regular Strength Pink Bismuthbismuth subsalicylateBismuth subsalicylate 525 mg/30mLSuspensionOralRITE AID CORPORATION11822-7060
RITE AID Ultra Strnght Pink Bismuthbismuth subsalicylateBismuth subsalicylate 525 mg/15mLSuspensionOralRITE AID CORPORATION11822-7070
Medique Diotamebismuth subsalicylateBismuth subsalicylate 262 mg/1Tablet, ChewableOralUnifirst First Aid Corporation47682-210
FEVIA Diarrhea Controlbismuth subsalicylateBismuth subsalicylate 262 mg/1Capsule, Liquid filledOralVIVUNT PHARMA LLC82706-028
5-Symptom Digestive Reliefbismuth subsalicylateBismuth subsalicylate 262 mg/1TabletOralTARGET CORPORATION11673-880
Topcare Stomach Relief Original Strengthbismuth subsalicylateBismuth subsalicylate 262 mg/1TabletOralTopCo Associates, LLC76162-001
Stomach Reliefbismuth subsalicylateBismuth subsalicylate 525 mg/30mLLiquidOralFamily Dollar (FAMILY WELLNESS)55319-560
Pepto Bismol CHEWABLESbismuth subsalicylateBismuth subsalicylate 262 mg/1Tablet, ChewableOralProcter & Gamble Manufactura S de RL de CV58933-002
Percy Medicinebismuth subsalicylateBismuth subsalicylate 1050 mg/10mLLiquidOralMerrick Medicine Company, Inc0322-2222
Bismuth Subsalicylate Suspension Regular Strengthbismuth subsalicylateBismuth subsalicylate 525 mg/30mLSuspensionOralAptaPharma Inc.76281-557
Pepto Bismol CHEWABLESbismuth subsalicylateBismuth subsalicylate 262 mg/1Tablet, ChewableOralProcter & Gamble Manufactura S de RL de CV58933-011
Stomach Relief - Regular Strengthbismuth subsalicylateBismuth subsalicylate 525 mg/30mLLiquidOralAptaPharma Inc.76281-537
Stomach Reliefbismuth subsalicylateBismuth subsalicylate 262 mg/1TabletOralChain Drug Marketing Association, Inc.83324-060
Stomach Relief - Maximum Strengthbismuth subsalicylateBismuth subsalicylate 1050 mg/30mLLiquidOralAptaPharma Inc.76281-538
Pepto Bismol Chewsbismuth subsalicylateBismuth subsalicylate 262 mg/1Tablet, ChewableOralThe Procter & Gamble Manufacturing Company37000-996
Stomach Relief, Maximum Strengthbismuth subsalicylateBismuth subsalicylate 1050 mg/30mLSuspensionOralAptaPharma Inc.76281-558
CVS Stomach Reliefbismuth subsalicylateBismuth subsalicylate 262 mg/1TabletOralCVS51316-124
Quality Choice Ultra Strength Stomach Reliefbismuth subsalicylateBismuth subsalicylate 525 mg/15mLLiquidOralQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)83324-337
Pepto Bismol CHEWABLESbismuth subsalicylateBismuth subsalicylate 525 mg/21Tablet, ChewableOralProcter & Gamble Manufactura S de RL de CV58933-013
POCKET PEPTO Pepto Bismolbismuth subsalicylateBismuth subsalicylate 262 mg/1TabletOralProcter & Gamble Manufactura S de RL de CV58933-017

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