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M-Dryl DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL Liquid, 120 mL — NDC 58657-0528-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

M-Dryl DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL Liquid, 120 mL — NDC 58657-528-04 (Billing 58657-0528-04)

by Method Pharmaceuticals, LLC · 120 mL in 1 BOTTLE

This is a package of 120 mL of M-Dryl DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL Liquid from Method Pharmaceuticals, LLC, marketed since Aug 2019 and currently FDA-listed; retail pharmacies pay about $0.0192 per mL (NADAC).

NDC 58657-0528-04
🏷️ FDA NDC (as labeled) 58657-528-04 billing pads the product segment with a zero
This package
Contains120 mL Cost per mL$0.0192 NADAC Per package$2.30 / 120 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0590/unit — full pricing hub ↓
Product page 58657-0528-16 Also comes in: 473 ml 58657-528-16
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58657-528-04
Product NDC 58657-528
11-digit billing NDC 58657052804
NCPDP billing unit ML — per mL (volume)
RxCUI 1049906
UNII TC2D6JAD40
Application # M012
SPL Set ID 5a60c923-8bb7-427f-9636-08ed5474f71b
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-08-01
Route ORAL
Dosage form LIQUID
Substance DIPHENHYDRAMINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 41200030100920
GPI class M-Dryl
GCN Seq No 016675
GCN 48831
HICL code 004480
Ingredient (HICL) Diphenhydramine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name M-DRYL 12.5 MG/5 ML SOLUTION
FDB brand name M-Dryl
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 016675
  • GCN: 48831
  • GPI-14 (Medi-Span): 41200030100920
  • HICL (First Databank): 004480
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 1049906
Why two NDCs? The FDA registers this code as 58657-528-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 58657-0528-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name M-DRYL 12.5 MG/5 ML SOLUTION Ingredient Diphenhydramine Hcl
📖 What it is MedlinePlus · NLM

Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Oral products temporarily relieve hay fever and other upper respiratory allergy symptoms like runny nose, sneezing and itchy, watery eyes. They also ease runny nose and sneezing fr...
  • Oral forms are generally taken every 4 to 6 hours, with no more than 6 doses in 24 hours. The amount depends on age and the product, so check the package chart or ask me or your do...
  • It can. Drowsiness is common, so be careful driving or using machinery. Alcohol, sedatives and tranquilizers make it worse, so avoid them.
  • Oral products are not for children under 2 years, and some are not for children under 6. Children can become excitable, and overdose can be very dangerous. Always follow the age di...
📖 Read our full Diphenhydramine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.019 $2.30 / 120 ml
Medicaid paysCMS SDUD · 12 mo $0.0590 $7.08 / 120 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.020 $0.018
▲ Up 10% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
58657-0528-04 You're viewing this 120 mL in 1 BOTTLE $0.0192 / mL $2.31 2019-08-01 — Active
58657-0528-16 58657-528-16 Main listing 473 mL in 1 BOTTLE $0.0174 / mL $8.25 2019-08-01 — Active

You're viewing the smallest of 2 pack sizes for this product.

Per mL, this pack runs about 10% above the cheapest pack (473 mL, $0.0174 vs $0.0192 NADAC).

This pack accounts for about 27% of this product's recent Medicaid fills; most go to the 473 ml pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 120 mL — 120 ml in 1 bottle.
How does this package differ from NDC 58657-0528-16?
Both are M-Dryl DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL Liquid — the drug itself is identical. This page's package is the 120 mL one, while NDC 58657-0528-16 is the 473 ml package. Per-mL NADAC also differs: $0.0192 here vs $0.0174 for the 473 ml pack.
What NDC number is used to bill for this package of M-Dryl DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Childrens Allergy 12.5 mg/5mL 63868-0370-04 QUALITY 1 bottle $0.016 — FDA listed save 17%
Childrens Allergy 12.5 mg/5mL 63868-0823-54 QUALITY 1 bottle $0.016 — FDA listed save 17%
Diphenhydramine HCl 12.5 mg/5mL 00904-6985-16 Major 473 ml $0.017 — Availability likely save 9%
Allergy Relief Childrens 12.5 mg/5mL 00904-7533-15 Major 473 ml $0.017 — Availability likely save 9%
Allergy Relief 12.5 mg/5mL 54859-0811-16 LLORENS 473 ml $0.017 — Availability likely save 9%
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 81033-0029-16 Kesin 473 ml $0.017 — Availability likely save 9%
Childrens Allergy Relief Dye Free 12.5 mg/5mL 70000-0693-01 CARDINAL 1 bottle $0.018 — Availability likely save 8%
good sense allergy 12.5 mg/5mL 00113-0379-26 L. 1 bottle $0.019 — Availability likely —
Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 24385-0379-26 Amerisource 1 bottle $0.019 — Availability likely —
Allergy Relief 50 mg/20mL 46122-0685-26 Amerisource 1 bottle $0.019 — Availability likely —
Good NeighborChildrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 46122-0793-29 AMERISOURCE 1 bottle $0.019 — Availability likely —
Diphenhydramine Oral Liquid 12.5 mg/5mL 57237-0305-12 Rising 118 ml $0.019 — Availability likely —
M-Dryl 12.5 mg/5mLthis 58657-0528-04 Method 120 ml $0.019 — Availability likely —
leader childrens allergy relief 12.5 mg/5mL 70000-0474-01 Cardinal 1 bottle $0.019 — Availability likely —
Childrens Allergy Relief 12.5 mg/5mL 70000-0701-01 Cardinal 1 bottle $0.019 — Availability likely —
foster and thrive childrens allergy relief 12.5 mg/5mL 70677-1268-01 Strategic 1 bottle $0.019 — Availability likely —
Diphenhydramine Hcl 12.5 Mg Per 5 Ml 12.5 mg/5mL 82568-0016-04 AARNA 118 ml $0.019 — Availability likely —
Foster and Thrive Childrens Allergy Relief 12.5 mg/5mL 70677-1012-01 Strategic 1 bottle $0.020 — Availability likely +3%
Quality Choice Dye Free Cherry Childrens Allergy Relief 12.5 mg/5mL 83324-0016-04 Chain 1 bottle $0.027 — FDA listed +43%
Diphenhydramine Hydrochloride 12.5 mg/5mL 00121-0489-00 PAI 10 cups — AA FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 00121-0865-00 PAI 10 cups — — FDA listed —
Diphenhydramine Hydrochloride 25 mg/10mL 00121-0978-00 PAI 10 cups — AA FDA listed —
Diphenhydramine HCl 25 mg/10mL 00121-1730-00 PAI 10 cups — — FDA listed —
Wal Dryl Childrens Allergy 12.5 mg/5mL 00363-0092-08 Walgreens 1 bottle — — FDA listed —
Dye Free Wal Dryl Allergy childrens 12.5 mg/5mL 00363-0293-04 Walgreens 1 bottle — — FDA listed —
childrens Allergy Dye Free Wal Dryl 12.5 mg/5mL 00363-0710-08 WALGREEN 1 bottle — — FDA listed —
childrens allergy relief 12.5 mg/5mL 00363-1236-26 Walgreen 1 bottle — — FDA listed —
Adult Allergy Relief Dye Free 25 mg/10mL 00363-7100-04 WALGREEN 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 00363-8018-36 Walgreen 1 bottle — — FDA listed —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 00904-7323-70 Major 100 cups — — Discontinued —
Diphenhydramine HCl Oral Solution 25 mg/10mL 00904-7324-72 Major 100 cups — — Discontinued —
Diphenhydramine HCl 25 mg/10mL 00904-7559-72 Major 10 cups — — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 00904-7560-70 Major 10 cups — — FDA listed —
Children Allergy Relief Bubblegum flavor 12.5 mg/5mL 11673-0832-04 TARGET 1 bottle — — FDA listed —
childrens allergy relief dye-free 12.5 mg/5mL 11673-0918-36 Target 1 bottle — — Discontinued —
Childrens Allergy Relief 12.5 mg/5mL 11822-0379-00 Rite 1 bottle — — FDA listed —
Childrens Dye Free Allergy Relief 12.5 mg/5mL 11822-0918-01 Rite 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 21130-0025-04 Safeway, 118 ml — — FDA listed —
Childrens Dye Free Allergy Relief 12.5 mg/5mL 21130-0563-05 BETTER 1 bottle — — Discontinued —
Bactimicina Childrens Allergy 12.5 mg/5mL 24286-1565-04 DLC 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 30142-0404-26 Kroger 1 bottle — — FDA listed —
childrens allergy 12.5 mg/5mL 30142-0651-26 Kroger 1 bottle — — FDA listed —
Topcare childrens allergy 12.5 mg/5mL 36800-0379-26 Topco 1 bottle — — FDA listed —
Allergy Childrens 12.5 mg/5mL 37808-0012-08 H 1 bottle — — FDA listed —
Allergy 12.5 mg/5mL 37808-0379-26 H 1 bottle — — FDA listed —
equaline allergy 12.5 mg/5mL 41163-0379-26 United 1 bottle — — FDA listed —
KROGER Dye Free Childrens Allergy Relief 12.5 mg/5mL 41226-0710-08 KROGER 1 bottle — — FDA listed —
allergy childrens 12.5 mg/5mL 41250-0379-26 Meijer 1 bottle — — FDA listed —
Meijer Childrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 41250-0710-08 MEIJER 1 bottle — — FDA listed —
CareOne Childrens Allergy Relief 12.5 mg/5mL 41520-0632-26 American 1 bottle — — FDA listed —
allergy 12.5 mg/5mL 42507-0379-26 HyVee 1 bottle — — FDA listed —
equate allergy relief 12.5 mg/5mL 49035-0379-26 Wal-Mart 1 bottle — — FDA listed —
Dye Free Childrens Allergy Relief 12.5 mg/5mL 49035-0600-04 WAL-MART 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 49580-0292-02 P 118 ml — — FDA listed —
Childrens Dye Free Allergy 12.5 mg/5mL 49580-0293-04 P 1 bottle — — FDA listed —
children allergy relief dye free cherry 12.5 mg/5mL 50090-6163-00 A-S 1 bottle — — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 50090-6541-00 A-S 118 ml — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 50090-7824-00 A-S 1 bottle — — FDA listed —
Childrens Benadryl ALLERGY 12.5 mg/5mL 50580-0534-04 Kenvue 1 bottle — — FDA listed —
Childrens Benadryl DYE-FREE ALLERGY 12.5 mg/5mL 50580-0535-01 Kenvue 1 bottle — — FDA listed —
BENADRYL Allergy 12.5 mg/5mL 50580-0573-04 Kenvue 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 50844-0015-19 L.N.K. 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 51316-0150-19 CVS 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 51316-0180-19 CVS 1 bottle — — FDA listed —
CVS dye-free childrens allergy 12.5 mg/5mL 51316-0710-08 CVS 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 53942-0505-24 DeMoulas 118 ml — — FDA listed —
Childrens Allergy 12.5 mg/5mL 53943-0505-26 Discount 237 ml — — FDA listed —
Allergy Relief 12.5 mg/5mL 54859-0837-04 LLORENS 118 ml — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 55319-0315-36 Family 1 bottle — — FDA listed —
Allergy Relief 12.5 mg/5mL 55319-0918-36 Family 1 bottle — — FDA listed —
Allergy Childrens 12.5 mg/5mL 55910-0124-36 DOLGENCORP, 1 bottle — — FDA listed —
dg health allergy childrens 12.5 mg/5mL 55910-0379-26 Dolgencorp, 1 bottle — — FDA listed —
Allergy Childrens Allergy 12.5 mg/5mL 55910-0891-04 Dolgencorp, 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 56062-0379-26 Publix 1 bottle — — FDA listed —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 57237-0317-51 Rising 100 cups — — FDA listed —
Diphenhydramine HCl Oral Solution 25 mg/10mL 57237-0318-11 Rising 100 cups — — FDA listed —
Geri Dryl 12.5 mg/5mL 57896-0980-16 GERI-CARE 473 ml — — FDA listed —
CVS Health Childrens Allergy Relief 12.5 mg/5mL 59779-0793-10 CVS 10 vials — — FDA listed —
allergy relief childrens 12.5 mg/5mL 59779-0874-26 CVS 1 bottle — — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 60687-0829-86 American 10 cups — — FDA listed —
Diphenhydramine HCl 25 mg/10mL 60687-0830-08 American 10 cups — — FDA listed —
M-Dryl 12.5 mg/5mL 63629-1159-01 Bryant 120 ml — — FDA listed —
M-Dryl 12.5 mg/5mL 63629-1160-01 Bryant 473 ml — — FDA listed —
Dye Free Allergy childrens 12.5 mg/5mL 63868-0128-04 QUALITY 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 63941-0292-04 Best 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 63941-0505-26 Best 1 bottle — — FDA listed —
Best Choice Childrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 63941-0710-04 BEST 1 bottle — — FDA listed —
Winco Foods Childrens Allergy Relief Dye Free 12.5 mg/5mL 67091-0354-18 WINCO 1 bottle — — FDA listed —
good sense allergy 12.5 mg/5mL 68071-3734-04 NuCare 1 bottle — — FDA listed —
ADWE dye-free childrens allergy 12.5 mg/5mL 68163-0710-08 RARITAN 1 bottle — — FDA listed —
Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 68788-7994-01 Preferred 1 bottle — — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 68788-8274-01 Preferred 118 ml — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 68998-0505-24 Marc 118 ml — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 69168-0471-59 Allegiant 1 bottle — — FDA listed —
Allergy Relief 12.5 mg/5mL 69256-0292-08 Harris 1 bottle — — Discontinued —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 69339-0151-17 Natco 10 cups — — FDA listed —
Diphenhydramine HCl Oral Solution 25 mg/10mL 69339-0152-17 Natco 10 cups — — FDA listed —
Kids Allergy 12.5 mg/5mL 69676-0039-09 Genexa 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 69676-0074-09 Genexa 1 bottle — — FDA listed —
Allergy Relief 50 mg/20mL 69842-0174-36 CVS 1 bottle — — Discontinued —
Childrens Allergy Relief 12.5 mg/5mL 69842-0719-19 CVS 1 bottle — — FDA listed —
Allergy Relief 50 mg/20mL 69842-0798-36 CVS 1 bottle — — FDA listed —
Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 71205-0259-04 Proficient 1 bottle — — FDA listed —
Max Allergy Kids 12.5 mg/5mL 71399-0023-04 Akron 118 ml — — FDA listed —
Diphenhydramine HCL STRAWBERRY FLAVOR 12.5 mg/5mL 71800-0058-19 Innovida 119 ml — — FDA listed —
Diphenhydramine Hydrochloride 25 mg/10mL 71872-7242-01 Medical 1 cup — AA FDA listed —
M-Dryl 12.5 mg/5mL 72162-1674-02 Bryant 120 ml — — FDA listed —
basic care childrens allergy relief 12.5 mg/5mL 72288-0379-26 Amazon.com 1 bottle — — FDA listed —
Dr Kids Allergy Relief 12.5 mg/5mL 73282-2521-01 CalmCo 24 vials — — FDA listed —
Calmco Allergy Relief 25 mg/10mL 73282-2524-02 CalmCo 18 vials — — FDA listed —
Diphenhydramine Oral Solution 12.5 mg/5mL 73564-0814-16 Aldama 1 bottle — — Discontinued —
Childrens Allergy 12.5 mg/5mL 76281-0505-24 AptaPharma 118 ml — — FDA listed —
Allergy Relief childrens 12.5 mg/5mL 79903-0175-08 WALMART 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 79903-0368-04 WALMART 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 79903-0411-04 WALMART 1 bottle — — FDA listed —
Puregen Labs Allergy Relief 12.5 mg/5mL 80513-0201-16 Advanced 473 ml — — FDA listed —
Childrens Allergy Relief Dye Free Bubble Gum 12.5 mg/5mL 81522-0293-04 FSA 1 bottle — — Discontinued —
Kosher Meds Childrens Allergy Relief 12.5 mg/5mL 82179-0004-04 Mollec 1 bottle — — FDA listed —
Target Dye Free Childrens Allergy Relief 12.5 mg/5mL 82442-0710-08 Target 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 82673-0109-04 KinderFarms, 1 bottle — — FDA listed —
Nighttime Cold and Cough 12.5 mg/5mL 82673-0191-04 KinderFarms, 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 83324-0326-04 Chain 1 bottle — — FDA listed —
QUALITY CHOICE Childrens Allergy Relief DYE FREE 12.5 mg/5mL 83324-0339-04 QUALITY 1 bottle — — FDA listed —
Diphenhydramine Hydrochloride 12.5 mg/5mL 83720-0502-04 Oncor 118 ml — — FDA listed —
Geri Dryl 12.5 mg/5mL 83939-0007-01 VERITYRX, 5 ml — — FDA listed —
M-Dryl 12.5 mg/5mL 83939-0008-01 VERITYRX, 5 ml — — FDA listed —
Revasol Childrens Allergy 12.5 mg/5mL 84379-0286-04 Rnv 118 ml — — FDA listed —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 84415-0012-01 Everpharm 100 cups — — FDA listed —
Diphenhydramine HCl Oral Solution 25 mg/10mL 84415-0013-01 Everpharm 100 cups — — FDA listed —
Diphenhydramine HCL 12.5 mg/5mL 84447-0103-01 Belleview 200000 ml — — FDA listed —
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution 12.5 mg/5mL 87078-0411-52 MEDWISE 12 pouches — — FDA listed —
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) 12.5 mg/5mL 87078-0421-52 MEDWISE 12 pouches — — FDA listed —
Diphenhydramine hydrochloride 12.5 mg/5mL 31722-0600-11 Camber 1 bottle — AA FDA listed —
Diphenhydramine HCL 12.5 mg/5mL 71741-0511-04 Redmont 118 ml — AA FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

FlavorCherry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

9 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesCherry Flavor, Citric Acid Anhydrous, FD&C red No. 40, Glycerin, Masking Agent, Propylene Glycol, Purified water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMethod Pharmaceuticals, LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code58657
First marketedAug 2019
Product typeHuman Otc Drug
Portfolio78 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

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

⏱️ Dosage and Administration 86 words ▾

Directions take every 4 to 6 hours use an accurate measuring device to administer this Medication children under 2 years do not use do not use children 2 to 5 years ask a doctor children 6 years to under 12 years 5 mL (1 tsp) to 10 mL (2 tsp); not more than 60 mL (12 tsp) in 24 hours adults and children 12 years and over 10 mL (2 tsp) to 20 mL (4 tsp); not more than 120 mL (24 tsp) in 24 hours

⚠️ Warnings 127 words ▾

Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast-feeding , ask a health professional before use.

Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 19 words ▾

Other information each tsp contains: sodium 5 mg store at 15° to 30°C (59° to 86°F) protect from freezing

🧪 Active Ingredient 14 words ▾

Active ingredient (in each 5 mL = 1 tsp) Diphenhydramine HCl ..................................................... 12.5 mg

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients Cherry Flavor, Citric Acid Anhydrous, FD&C red No. 40, Glycerin, Masking Agent, Propylene Glycol, Purified water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution.

🎯 Purpose 1 words ▾

Purpose

📄 Ask a Doctor Before Use If 26 words ▾

Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

📄 When Using This Product 34 words ▾

When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast-feeding , ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 27 words ▾

Questions? Serious side effects associated with use of this product may be reported to this number. Call 1-877-250-3427 Mon. - Fri. (8 a.m. to 5 p.m. CST).

📄 Package Label / Principal Display Panel 38 words ▾

PRINCIPAL DISPLAY PANEL NDC 58657-528-04 M-Dryl Diphenhydramine Hydrochloride Oral Solution Antihistamine Cherry Flavor 4 fl. oz. (120 mL) label1

PRINCIPAL DISPLAY PANEL NDC 58657-528-16 M-Dryl Diphenhydramine Hydrochloride Oral Solution Antihistamine Cherry Flavor 16 fl. oz. (473 mL) label2

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
14.6K
Units reimbursed last 4 qtrs
1.8M
Gross reimbursed last 4 qtrs
$108.2K
Avg / prescription
$7.43
Avg / unit
$0.0590
Latest quarter Q1 2026
2.5KRx
Medicaid pays / mL
$0.0590
gross reimbursed
vs
NADAC / mL
$0.0192
acquisition cost
=
Spread
+$0.0398
+207% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
33% FFS 67% MCO
Fee-for-service · 4,761 Rx Managed care · 9,800 Rx
State Medicaid map
Alaska: no data reported AK Maine: 4,990 units · 358 per 100k residents ME Washington: 57,481 units · 736 per 100k residents WA Idaho: no data reported ID Montana: 966 units · 85.3 per 100k residents MT North Dakota: no data reported ND Minnesota: 31,555 units · 550 per 100k residents MN Wisconsin: 74,585 units · 1,262 per 100k residents WI Michigan: 67,194 units · 669 per 100k residents MI New York: 154,208 units · 788 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 18,651 units · 441 per 100k residents OR Nevada: 18,229 units · 571 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 10,354 units · 323 per 100k residents IA Illinois: 161,112 units · 1,284 per 100k residents IL Indiana: 15,567 units · 227 per 100k residents IN Ohio: 81,571 units · 692 per 100k residents OH Pennsylvania: 4,709 units · 36.3 per 100k residents PA New Jersey: 95,324 units · 1,026 per 100k residents NJ Massachusetts: 52,803 units · 754 per 100k residents MA California: 177,831 units · 456 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 23,644 units · 1,195 per 100k residents NE Missouri: 61,115 units · 986 per 100k residents MO Kentucky: 89,845 units · 1,985 per 100k residents KY West Virginia: 10,281 units · 581 per 100k residents WV Virginia: 20,614 units · 237 per 100k residents VA Maryland: 62,900 units · 1,018 per 100k residents MD Connecticut: 38,265 units · 1,058 per 100k residents CT Rhode Island: 19,019 units · 1,737 per 100k residents RI Arizona: 48,705 units · 655 per 100k residents AZ New Mexico: 24,675 units · 1,167 per 100k residents NM Kansas: 16,182 units · 550 per 100k residents KS Arkansas: 22,512 units · 734 per 100k residents AR Tennessee: 61,189 units · 859 per 100k residents TN North Carolina: 2,750 units · 25.4 per 100k residents NC South Carolina: no data reported SC Delaware: 8,936 units · 867 per 100k residents DE Oklahoma: no data reported OK Louisiana: 989 units · 21.6 per 100k residents LA Mississippi: 36,305 units · 1,235 per 100k residents MS Alabama: no data reported AL Georgia: 24,775 units · 225 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 235,095 units · 771 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
21.61,985
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 1,985 /100k
2 Rhode Island 1,737 /100k
3 Illinois 1,284 /100k
4 Wisconsin 1,262 /100k
5 Mississippi 1,235 /100k
6 Nebraska 1,195 /100k
7 New Mexico 1,167 /100k
8 Connecticut 1,058 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
473 ml58657-0528-16 39,630 Rx · $287,063
120 ml this page58657-0528-04 14,561 Rx · $108,216
Drug total (last 4 qtrs): 54,191 Rx · 8,635,501 units · $395,279 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 58657-0525-04 · Method 58657-0602-01 · Method →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.