NDC codes

FDA NDC Directory
Product NDC (as listed)58552-355Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58552-0355Add 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
58552-355-015855203550158552035501100 TABLET in 1 BOTTLE (58552-355-01)Marketed from Oct 1, 2026
58552-355-0258552035502585520355022 TABLET in 1 BLISTER PACK (58552-355-02)Marketed from Oct 1, 2026

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)
Giltuss TR
Generic name (nonproprietary)
guaifenesin,dextromethorphan hbr,phenylephrine hcl
Active ingredients
Guaifenesin — 390 mg/1Dextromethorphan hydrobromide — 29 mg/1Phenylephrine hydrochloride — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Gil Pharmaceutical CorpNDC labeler code 58552
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 012
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 58552-355_5d179277-c695-964e-e063-6294a90a7348SPL ID 5d179277-c695-964e-e063-6294a90a7348
Pharmacologic class
Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist

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

N458552035501 followed by a unit qualifier and the quantity

Package 58552-0355-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 58552-355

What is NDC 58552-355?
58552-355 is the product NDC for Giltuss TR, Guaifenesin 390 mg/1 + 2 more ingredients tablet, listed with the FDA by Gil Pharmaceutical Corp. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Giltuss TR (Guaifenesin,Dextromethorphan HBr,Phenylephrine HCl).
What is the active ingredient?
Guaifenesin, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.
Who is the labeler?
Gil Pharmaceutical Corp, NDC labeler code 58552. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Giltuss TR?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 012

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

FDA NDC Directory listings under M 012
ProductStrengthForm · routeLabelerProduct NDC
Tukol Cough and Congestiondextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochlorideDextromethorphan hydrobromide 10 mg/5mL + 2 more ingredientsSyrupOralGenomma Lab USA50066-510
DayTime Cold Flu Non Drowsyacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralHarris Teeter, LLC69256-898
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Packdextromethorphan hbr and doxylamine succinate—KitReckitt Benckiser LLC72854-083
Cabinet Allergy Relief Refill Diphenhydramine HCIdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1TabletOralCabinet Health P.B.C.82725-3001
MGC Health Cough Drops Honey HerbmentholMenthol 2 mg/1LozengeOralMedical Group Care LLC83173-143
Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralShield Pharmaceuticals Corp83059-0021
Vicks NyQuil VapoCOOL COLD and FLUacetaminophen, doxylamine succinate, dextromethorphan hydrobromideAcetaminophen 325 mg/1 + 2 more ingredientsTablet, CoatedOralThe Procter & Gamble Manufacturing Company84126-353
Cold and Flu Severeacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hclAcetaminophen 325 mg/1 + 3 more ingredientsTablet, Film coatedOralRite Aid Corporation11822-5031
EZ Nite Sleepdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLLiquidOralSafeway, Inc.21130-014
Chest Rubcamphor, eucalyptus oil, mentholCamphor (Synthetic) 48 mg/g + 2 more ingredientsJellyTopicalTopco Associates LLC36800-596
Maximum Strength Mucus Relief DMdextromethorphan hydrobromide and guaifenesinDextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mLLiquidOralWal-Mart Stores,Inc.,49035-839
DM Maximumdextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mLSolutionOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-310
Nighttime Cold And Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsSolutionOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-884
Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralStrategic Sourcing Services LLC62011-0256
Dual Action Glacier Mint Cough Suppressant Oral AnestheticmentholMenthol 8.3 mg/1LozengeOralRicola USA Inc.63667-603
Nighttime Severe Cold and Coughacetaminophen, diphenhydramine, phenylephrineAcetaminophen 650 mg/1 + 2 more ingredientsPowder, For solutionOralRARITAN PHARMACEUTICALS INC68163-541
Daytime Nighttime Cold Flu Reliefacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl—KitHarris Teeter, LLC69256-901
HBP Chest Congestion and Cough Reliefguaifenesin and dextromethorphan hydrobromideDextromethorphan hydrobromide 10 mg/1; Guaifenesin 200 mg/1Capsule, Liquid filledOralWalgreens0363-6681
Sinus Relief Severe Congestion and Painacetaminophen, guaifenesin, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsTablet, CoatedOralCARDINAL HEALTH70000-0080
Severe Congestion and Painacetaminophen, guaifenesin, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsTablet, CoatedOralRetail Business Services , LLC.72476-167

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