Over-the-counter drug · OTC MONOGRAPH DRUG
M-Dryl (Diphenhydramine hydrochloride) NDC 58657-528
Diphenhydramine hydrochloride 12.5 mg/5mL · Liquid · Oral · Method Pharmaceuticals, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)58657-528Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58657-0528Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58657-528-04 | 58657052804 | 120 mL in 1 BOTTLE (58657-528-04)Marketed from Aug 1, 2019 | |
| 58657-528-16 | 58657052816 | 473 mL in 1 BOTTLE (58657-528-16)Marketed from Aug 1, 2019 |
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)
- M-Dryl
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 12.5 mg/5mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Method Pharmaceuticals, LLCNDC labeler code 58657
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58657-528_41b56261-e688-a46d-e063-6394a90a9246SPL ID 41b56261-e688-a46d-e063-6394a90a9246SPL set ID 5a60c923-8bb7-427f-9636-08ed5474f71bRxCUI 1049906UNII TC2D6JAD40
- Pharmacologic class
- Histamine-1 Receptor Antagonist
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
N458657052804followed by a unit qualifier and the quantityPackage 58657-0528-04. 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 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 58657-528
- What is NDC 58657-528?
- 58657-528 is the product NDC for M-Dryl (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 12.5 mg/5mL liquid, listed with the FDA by Method Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- M-Dryl (Diphenhydramine hydrochloride).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Method Pharmaceuticals, LLC, NDC labeler code 58657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for M-Dryl?
- 4 other product NDCs are listed under this name. See all M-Dryl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other M-Dryl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| M-Dryldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | Bryant Ranch Prepack | 72162-1674 | 72162-1674-0272162-1674-04 |
| M-Dryldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | VERITYRX, LLC | 83939-0008 | 83939-0008-0183939-0008-0283939-0008-03+2 more |
| M-Dryldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | Bryant Ranch Prepack | 63629-1159 | 63629-1159-01 |
| M-Dryldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | Bryant Ranch Prepack | 63629-1160 | 63629-1160-01 |
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 |
|---|---|---|---|---|
| topcare tussin cf maxacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Topco Associates LLC | 76162-000 |
| SEVERE CONGESTION and COUGH MAXdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/20mL + 2 more ingredients | LiquidOral | AptaPharma Inc. | 76281-517 |
| Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide, and doxylamine succinate | Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-304 |
| Quality Choice Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Chain Drug Marketing Association | 83324-194 |
| Pseudoephedrine Hydrochloride | Pseudoephedrine hydrochloride 60 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6728 |
| Nighttime Cold and Flu Liquidacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | TARGET CORPORATION | 11673-287 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | TARGET CORPORATION | 11673-494 |
| Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | KROGER COMPANY | 41226-272 |
| sinus pressure and pain peacetaminophen and phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, CoatedOral | GOODSENSE | 50804-220 |
| Mucinex Sinus-Max Severe Congestion Reliefacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Reckitt Benckiser LLC | 63824-201 |
| Oxymetazoline Hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | CHAIN DRUG MARKETING ASSOCIATION INC. | 63868-676 |
| Childrens Wal Tap Elixer Cold and Allergybrompheniramine maleate, phenylephrine hcl | Brompheniramine maleate 2 mg/10mL; Phenylephrine hydrochloride 5 mg/10mL | LiquidOral | Walgreens | 0363-0312 |
| Vicks NyQuil Kids BERRY COLD and COUGH plus RUNNY NOSEchlorpheniramine maleate, dextromethorphan hbr | Chlorpheniramine maleate 2 mg/15mL; Dextromethorphan hydrobromide 15 mg/15mL | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-779 |
| Night-Time Cold and Flu Reliefacetaminophen, doxylamine succinate, dextromethorphan hbr | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | HealthLife of USA | 69517-161 |
| Tylenol Sinus Severeacetaminophen | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | R J General Corporation | 70264-026 |
| Tussin Expectorantguaifenesin | Guaifenesin 100 mg/5mL | LiquidOral | AptaPharma, Inc. | 76281-507 |
| ValuMeds Allergy Relief Antihistamine Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1101 |
| Equate Severe Menthol Throat Dropmenthol | Menthol 20 mg/1 | LozengeOral | Walmart | 79903-254 |
| Nighttime Cold And Flu Relief Softgels Multi-Symptomacetaminophen, dextromethorphan hbr, doxylamine succinate | Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients | Capsule, Gelatin coatedOral | Advanced Rx LLC | 80513-302 |
| Vicks NyQuil-D COLD and SINUS plus SEVERE CONGESTIONacetaminophen, pseudoephedrine hcl, doxylamine succinate, dextromethorphan hbr | Doxylamine succinate 6.25 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | The Procter & Gamble Manufacturing Company | 84126-364 |
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