Over-the-counter drug · OTC MONOGRAPH DRUG
Childrens Giltuss EX Expectorant (Guaifenesin) NDC 58552-146
Guaifenesin 200 mg/5mL · Solution · Oral · Gil Pharmaceutical Corp
NDC codes
FDA NDC DirectoryProduct NDC (as listed)58552-146Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58552-0146Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58552-146-04 | 58552014604 | 1 BOTTLE in 1 CARTON (58552-146-04) / 118 mL in 1 BOTTLEMarketed from Jun 22, 2020 |
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)
- Childrens Giltuss EX Expectorant
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 200 mg/5mL
- Dosage form
- Solution
- 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
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 58552-146_40b92b1e-3784-2ed2-e063-6394a90a8737SPL ID 40b92b1e-3784-2ed2-e063-6394a90a8737SPL set ID a8c59e6d-c11c-2664-e053-2a95a90a8333RxCUI 310625UNII 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
N458552014604followed by a unit qualifier and the quantityPackage 58552-0146-04. 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 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.
About NDC 58552-146
- What is NDC 58552-146?
- 58552-146 is the product NDC for Childrens Giltuss EX Expectorant (guaifenesin), Guaifenesin 200 mg/5mL solution, listed with the FDA by Gil Pharmaceutical Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Giltuss EX Expectorant (Guaifenesin).
- What is the active ingredient?
- Guaifenesin.
- 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 Childrens Giltuss EX Expectorant?
- 1 other product NDC are listed under this name. See all Childrens Giltuss EX Expectorant NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens Giltuss EX Expectorant products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Childrens Giltuss EX Expectorantguaifenesin | Guaifenesin 200 mg/5mL | SolutionOral | Dextrum Laboratories Inc. | 65852-016 | 65852-0016-04 |
Other NDCs under M 012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Childrens Benadryl ALLERGYdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Kenvue Brands LLC | 50580-534 |
| Cold Maxacetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-138 |
| Kroger DayTime Cold and Flu SOFTGELacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | The Kroger Co. | 59450-046 |
| CVS Overnight Cold and Flu Clear and Coolacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | CVS PHARMACY, INC | 69842-966 |
| Sinus Head Congestionacetaminophen, phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Capsule, Liquid filledOral | VIVUNT PHARMA LLC | 82706-025 |
| Leader Cough Drops Vanilla Honeymenthol | Menthol, Unspecified form 2.5 mg/1 | LozengeOral | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 83698-692 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | HEB | 37808-590 |
| Oxymetazoline Hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | Bi-Mart | 37835-996 |
| Vaporxcamphor (synthetic), eucalyptus oil, and menthol | Camphor (Synthetic) .048 g/g + 2 more ingredients | OintmentTopical | AKRON PHARMA INC | 71399-4589 |
| Global Care 4Oz Vapor Rubmenthol, camphor, eucalyptus oil | Menthol 1 g/100g + 2 more ingredients | OintmentTopical | GLOBAL IMPORT SALES LLC | 72146-008 |
| Adult Allergy Reliefcalmco allergy relief | Diphenhydramine hydrochloride 25 mg/1 | Bar, ChewableOral | CalmCo | 73282-2520 |
| Severe cold and flu Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci | Acetaminophen 650 mg/30mL + 3 more ingredients | LiquidOral | P & L Development, LLC | 49580-4160 |
| Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-packacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride | — | Kit | Kenvue Brands LLC | 50580-526 |
| Daytime and Nighttimeacetaminophen, guaifenesin, dextromethorphan hbr, doxylamine succinate | — | KitOral | CVS HEALTH CORP | 51316-961 |
| Alka-Seltzer Plus Severe Cold Powerfast Fizz Nightaspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate | Aspirin 500 mg/1 + 3 more ingredients | Tablet, EffervescentOral | Bayer HealthCare LLC. | 0280-0021 |
| Sinus Pressure plus Pain PEacetaminophen and phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-220 |
| Daytime Cold And Flu Multi-Symptom Reliefacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | CapsuleOral | Chain Drug Consortium, LLC | 68016-877 |
| Sugar Free Cough Drops Black Cherrymenthol | Menthol 5.8 mg/1 | PastilleOral | Cardinal Health 110, Inc. | 70000-0643 |
| Multi-Symptom Cold childrensdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | SolutionOral | WALMART INC. | 79903-176 |
| AXIV DayTime - Liquidacetaminophen, dextromethorphan hydrobromide | Acetaminophen 650 mg/30mL; Dextromethorphan hydrobromide 20 mg/30mL | LiquidOral | VIVUNT PHARMA LLC | 82706-022 |
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