Over-the-counter drug · OTC MONOGRAPH DRUG

Topcare Stool Softener (Docusate sodium) NDC 76162-761

Docusate sodium 100 mg/1 · Capsule, Liquid filled · Oral · TOPCO ASSOCIATES LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)76162-761Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76162-0761Add 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
76162-761-25761620761251 BOTTLE in 1 CARTON (76162-761-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Jul 20, 2021

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)
Topcare Stool Softener
Generic name (nonproprietary)
docusate sodium
Active ingredients
Docusate sodium — 100 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
TOPCO ASSOCIATES LLCNDC labeler code 76162
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 007
Marketing start
Listing expires
Identifiers
Product ID 76162-761_ea68a2b3-9063-4a8b-a5a4-605abd4c23deSPL ID ea68a2b3-9063-4a8b-a5a4-605abd4c23deSPL set ID 93158bd3-c830-4b12-ab1c-133a4bdb9c78RxCUI 1115005UNII F05Q2T2JA0UPC 0036800160323

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

N476162076125 followed by a unit qualifier and the quantity

Package 76162-0761-25. 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 occasional constipation (irregularity) generally produces a bowel movement in 12 to 72 hours

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76162-761

What is NDC 76162-761?
76162-761 is the product NDC for Topcare Stool Softener (docusate sodium), Docusate sodium 100 mg/1 capsule, liquid filled, listed with the FDA by TOPCO ASSOCIATES LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Topcare Stool Softener (Docusate sodium).
What is the active ingredient?
Docusate sodium.
Who is the labeler?
TOPCO ASSOCIATES LLC, NDC labeler code 76162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Topcare Stool Softener?
2 other product NDCs are listed under this name. See all Topcare Stool Softener 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 Topcare Stool Softener NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Topcare Stool Softenerdocusate sodiumDocusate sodium 100 mg/1Capsule, Liquid filledOralTOPCO ASSOCIATES LLC76162-77776162-0777-99
Topcare Stool Softenerdocusate sodiumDocusate sodium 100 mg/1Capsule, Liquid filledOralTopCo Associates, LLC76162-00676162-0006-0176162-0006-6076162-0006-81

Other NDCs under M 007

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

FDA NDC Directory listings under M 007
ProductStrengthForm · routeLabelerProduct NDC
Stool Softener Laxativedocusate sodiumDocusate sodium 100 mg/1Capsule, Liquid filledOralUnited Natural Foods, Inc. dba UNFI41163-241
Milk Of Magnesiamagnesium hydroxideMagnesium hydroxide 1200 mg/15mLLiquidOralDOLGENCORP, INC.55910-649
Stool Softenerdocusate sodiumDocusate sodium 100 mg/1Capsule, Liquid filledOralReliable 1 Laboratories LLC69618-086
Magnesium CitrateMagnesium citrate 1.745 g/29.6mLLiquidOralThe Kroger Co.30142-899
citromamagnesium citrateMagnesium citrate 1.745 g/29.6mLLiquidOralVi-Jon, LLC0869-0164
Magnesium CitrateMagnesium citrate 1.745 g/29.6mLSolutionOralPublix Super Markets, Inc.56062-264
Careonepsyllium huskPsyllium husk .52 g/1CapsuleOralFOODHOLD USA41520-907
Stool Softenerdocusate sodiumDocusate sodium 100 mg/1Capsule, Liquid filledOralA-S Medication Solutions50090-7167
Sennosides, Docusate SodiumDocusate sodium 50 mg/1; Sennosides 8.6 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0195
Magnesium CitrateMagnesium citrate 1.745 g/29.6mLSolutionOralPublix Super Markets, Inc.56062-266
Mineral oilMineral oil 100 mg/100mLOilOralP & L Development, LLC49580-0334
Purifi Hand Sanitizerbenzalkonium chlorideBenzalkonium chloride .13 g/100mLSolutionTopicalPurifi LLC80659-301
Stool Softener Laxativedocusate sodiumDocusate sodium 100 mg/1Capsule, Liquid filledOralCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-0091
CareOne Milk of Magnesia Cherrymagnesium hydroxideMagnesium hydroxide 1200 mg/15mLLiquidOralRetail Business Services, LLC.72476-665
Stool Softener Laxative Extra Strengthdocusate sodiumDocusate sodium 250 mg/1Capsule, Liquid filledOralWALMART INC. (see also Equate)79903-073
Dulcolax Pink Stool Softenerdocusate sodiumDocusate sodium 100 mg/1Capsule, Liquid filledOralChattem, Inc.41167-0281
Quality Choice Laxativesodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified formSodium phosphate, Dibasic, Unspecified form 7 g/118mL; Sodium phosphate, Monobasic, Unspecified form 19 g/118mLEnemaRectalChain Drug Marketing Association83324-292
Magnesium CitrateMagnesium citrate 1.745 g/29.6mLLiquidOralSTRATEGIC SOURCING SERVICES70677-1112
Stool Softenerdocusate sodiumDocusate sodium 100 mg/1Capsule, Liquid filledOralBryant Ranch Prepack72162-2255
Milk of Magnesia Concentratemagnesium hydroxideMagnesium hydroxide 2400 mg/10mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-0940

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