Over-the-counter drug · ANDA

Mucus Relief Maximum Strength (Mucus relief) NDC 69168-460

Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Allegiant Health

NDC codes

FDA NDC Directory
Product NDC (as listed)69168-460Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0460Add 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
69168-460-3269168046032100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-460-32)Marketed from Apr 23, 2024
69168-460-506916804605050 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-460-50)Marketed from Apr 23, 2024
69168-460-9869168046098200 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-460-98)Marketed from Mar 7, 2025

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)
Mucus Relief Maximum StrengthSuffix: Maximum Strength
Generic name (nonproprietary)
mucus relief
Active ingredients
Guaifenesin — 1200 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Allegiant HealthNDC labeler code 69168
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213420
Marketing start
Listing expires
Other FDA classes
Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 69168-460_da2863ab-6f89-4220-aa26-9fcd69f7cc5bSPL ID da2863ab-6f89-4220-aa26-9fcd69f7cc5bSPL set ID 3d6c30d7-cd02-44a2-b48e-cd65f2896bfdRxCUI 310621UNII 495W7451VQ
Pharmacologic class
Expectorant

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

N469168046032 followed by a unit qualifier and the quantity

Package 69168-0460-32. 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)

Use(s) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69168-460

What is NDC 69168-460?
69168-460 is the product NDC for Mucus Relief Maximum Strength (mucus relief), Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Allegiant Health. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mucus Relief Maximum Strength (Mucus Relief).
What is the active ingredient?
Guaifenesin.
Who is the labeler?
Allegiant Health, NDC labeler code 69168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mucus Relief Maximum Strength?
4 other product NDCs are listed under this name. See all Mucus Relief Maximum Strength 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 Mucus Relief Maximum Strength NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Mucus Relief Maximum StrengthguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralHARRIS TEETER72036-20472036-0204-02
Mucus Relief Maximum StrengthguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralWINCO FOODS, LLC67091-40467091-0404-02
Mucus Relief Maximum StrengthguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralDemoulas Super Markets, Inc53942-20453942-0204-02
Mucus Relief Maximum StrengthguaifenesinGuaifenesin 1200 mg/1TabletOralCare One (American Sales Company)41520-73241520-0732-14

Other NDCs under ANDA 213420

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

FDA NDC Directory listings under ANDA 213420
ProductStrengthForm · routeLabelerProduct NDC
Mucus ReliefGuaifenesin 600 mg/1Tablet, Extended releaseOralAllegiant Health69168-459
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralBi-Mart37835-408
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralBi-Mart37835-412
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralProficient Rx LP82804-265
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-096
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-097
Dr. Simi Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralFarmacias De Similares TX LLC85786-302
dg health mucus er maxguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralDolgencorp Inc55910-626
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralSafrel Pharmaceuticals, LLC.71309-461
Curist Mucus Relief Maximum StrengthguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralLittle Pharma, Inc.72559-013
Curist Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralLittle Pharma, Inc.72559-017
GuaifenesinGuaifenesin 600 mg/1TabletOralWalgreens0363-9569
Mucus Relief Maximum StrengthguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralHARRIS TEETER72036-204
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralHARRIS TEETER72036-203
Guaifenesin - Odaat 1200 MgguaifenesinGuaifenesin 1200 mg/1TabletOralLODAAT LLC83139-175
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAMERIFOODS TRADING COMPANY61504-204
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralNUVICARE LLC84324-026
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mgguaifenesinGuaifenesin 600 mg/1TabletOralTWIN MED LLC55681-301
Mucus Relief Maximum StrengthguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralWINCO FOODS, LLC67091-404
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralWINCO FOODS, LLC67091-403

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