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Diphenhydramine Oral Liquid Diphenhydramine Hydrochloride 12.5 mg/5mL Liquid, 473 mL — NDC 57237-0305-16 package photo

Diphenhydramine Oral Liquid Diphenhydramine Hydrochloride 12.5 mg/5mL Liquid, 473 mL

by Rising Pharma Holdings, Inc. · 473 mL in 1 BOTTLE (57237-305-16)
NDC 57237-0305-16
🏷️ FDA NDC (as labeled) 57237-305-16 billing pads the product segment with a zero
This package
Contains473 mL Cost per mL$0.0175 NADAC Per package$8.28 / 473 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0410/unit — full pricing hub ↓
Also comes in: 118 ml 57237-0305-12
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 57237-305-16
Product NDC 57237-305
11-digit billing NDC 57237030516
NCPDP billing unit ML — per mL (volume)
RxCUI 1049906
UNII TC2D6JAD40
Application # M009.50
SPL Set ID d8462e6f-a9fb-4701-97e2-d81a47f3e196
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 2022-12-19
Route ORAL
Dosage form LIQUID
Substance DIPHENHYDRAMINE HYDROCHLORIDE
GPI-14 41200030100920
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 DIPHENHYDRAMINE 12.5 MG/5 ML
FDB brand name Diphenhydramine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 57237-305-16 — 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 → 57237-0305-16. 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.

🏭 Manufacturer & labeler

LabelerRising Pharma Holdings, Inc.
FDA applicationM009.50 (OTC MONOGRAPH DRUG)
Labeler code57237
First marketedDec 2022
Product typeHuman Otc Drug
Portfolio525 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.

🩺 Clinical

Label name DIPHENHYDRAMINE 12.5 MG/5 ML 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
  • Diphenhydramine is mainly used to temporarily ease the stuffy, sneezy, itchy symptoms of allergies — like hay fever — and the common cold. Think runny nose, sneezing, watery or itc...
  • What exactly does diphenhydramine treat?
  • Yes, and that's one of the most important things to know about this medicine. Drowsiness is one of its most common effects — it crosses into the brain and that's what causes the se...
  • It depends on your child's age and the product. Most oral diphenhydramine products are not recommended for children under 6, and liquid products labeled for children are generally...
📖 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.

💊 What it looks like

Color Pink
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 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • 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 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 C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

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.

💲 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 $0.018 $8.28 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0410 $19.39 / 473 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 2023 Dec 2025 Apr 2026 Aug 2026 $0.018 $0.014
▲ Up 26% over the last 12 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Childrens Allergy 12.5 mg/5mL 63868-0370-04 QUALITY 1 bottle $0.016 — FDA listed save 9%
Childrens Allergy 12.5 mg/5mL 63868-0823-54 QUALITY 1 bottle $0.016 — FDA listed save 9%
Childrens Allergy Relief Dye Free 12.5 mg/5mL 70000-0693-01 CARDINAL 1 bottle $0.016 — Availability likely save 9%
Diphenhydramine HCl 12.5 mg/5mL 00904-6985-16 Major 473 ml $0.018 — Availability likely —
Allergy Relief Childrens 12.5 mg/5mL 00904-7533-15 Major 473 ml $0.018 — Availability likely —
Allergy Relief 12.5 mg/5mL 54859-0811-16 LLORENS 473 ml $0.018 — Availability likely —
Diphenhydramine Oral Liquid 12.5 mg/5mLthis 57237-0305-16 Rising 473 ml $0.018 — Availability likely —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 81033-0029-16 Kesin 473 ml $0.018 — Availability likely —
good sense allergy 12.5 mg/5mL 00113-0379-26 L. 1 bottle $0.020 — Availability likely +12%
Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 24385-0379-26 Amerisource 1 bottle $0.020 — Availability likely +12%
Allergy Relief 50 mg/20mL 46122-0685-26 Amerisource 1 bottle $0.020 — Availability likely +12%
Good NeighborChildrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 46122-0793-29 AMERISOURCE 1 bottle $0.020 — Availability likely +12%
M-Dryl 12.5 mg/5mL 58657-0528-04 Method 120 ml $0.020 — Availability likely +12%
leader childrens allergy relief 12.5 mg/5mL 70000-0474-01 Cardinal 1 bottle $0.020 — Availability likely +12%
Childrens Allergy Relief 12.5 mg/5mL 70000-0701-01 Cardinal 1 bottle $0.020 — Availability likely +12%
foster and thrive childrens allergy relief 12.5 mg/5mL 70677-1268-01 Strategic 1 bottle $0.020 — Availability likely +12%
Diphenhydramine Hcl 12.5 Mg Per 5 Ml 12.5 mg/5mL 82568-0016-04 AARNA 118 ml $0.020 — Availability likely +12%
Foster and Thrive Childrens Allergy Relief 12.5 mg/5mL 70677-1012-01 Strategic 1 bottle $0.020 — Availability likely +13%
Quality Choice Dye Free Cherry Childrens Allergy Relief 12.5 mg/5mL 83324-0016-04 Chain 1 bottle $0.027 — FDA listed +57%
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 — — FDA listed —
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 — — FDA listed —
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

🏛️
2022
On the market since
Dec 2022
📍
2026
Currently FDA-listed
4 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.

🗺️ 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 57237-0305-16, 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 – Q4 2025 · 4 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
50.2K
Units reimbursed last 4 qtrs
7.3M
Gross reimbursed last 4 qtrs
$299.4K
Avg / prescription
$5.97
Avg / unit
$0.0410
Latest quarter Q4 2025
10.6KRx
Medicaid pays / mL
$0.0410
gross reimbursed
vs
NADAC / mL
$0.0175
acquisition cost
=
Spread
+$0.0235
+134% 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 ⓘ
36% FFS 64% MCO
Fee-for-service · 18,001 Rx Managed care · 32,157 Rx
State Medicaid map
Alaska: no data reported AK Maine: 19,065 units · 1,367 per 100k residents ME Washington: 53,261 units · 682 per 100k residents WA Idaho: no data reported ID Montana: 4,171 units · 368 per 100k residents MT North Dakota: no data reported ND Minnesota: 165,523 units · 2,885 per 100k residents MN Wisconsin: 234,023 units · 3,960 per 100k residents WI Michigan: 488,633 units · 4,868 per 100k residents MI New York: 970,960 units · 4,961 per 100k residents NY Vermont: no data reported VT New Hampshire: 12,304 units · 878 per 100k residents NH Oregon: 15,543 units · 367 per 100k residents OR Nevada: 71,544 units · 2,240 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 44,047 units · 1,373 per 100k residents IA Illinois: 604,026 units · 4,813 per 100k residents IL Indiana: 127,100 units · 1,852 per 100k residents IN Ohio: 432,302 units · 3,668 per 100k residents OH Pennsylvania: 199,755 units · 1,541 per 100k residents PA New Jersey: 482,074 units · 5,189 per 100k residents NJ Massachusetts: 237,720 units · 3,396 per 100k residents MA California: 969,700 units · 2,489 per 100k residents CA Utah: 5,835 units · 171 per 100k residents UT Colorado: no data reported CO Nebraska: 154,190 units · 7,795 per 100k residents NE Missouri: 184,651 units · 2,980 per 100k residents MO Kentucky: 382,333 units · 8,447 per 100k residents KY West Virginia: 31,366 units · 1,772 per 100k residents WV Virginia: 74,783 units · 858 per 100k residents VA Maryland: 139,055 units · 2,250 per 100k residents MD Connecticut: 83,849 units · 2,318 per 100k residents CT Rhode Island: 130,717 units · 11,938 per 100k residents RI Arizona: 217,786 units · 2,931 per 100k residents AZ New Mexico: 43,009 units · 2,034 per 100k residents NM Kansas: 56,918 units · 1,936 per 100k residents KS Arkansas: 56,073 units · 1,828 per 100k residents AR Tennessee: 33,079 units · 464 per 100k residents TN North Carolina: 62,578 units · 578 per 100k residents NC South Carolina: 54,588 units · 1,016 per 100k residents SC Delaware: 49,882 units · 4,838 per 100k residents DE Oklahoma: no data reported OK Louisiana: 6,270 units · 137 per 100k residents LA Mississippi: 73,356 units · 2,495 per 100k residents MS Alabama: no data reported AL Georgia: 273,471 units · 2,480 per 100k residents GA D.C.: no data reported DC Hawaii: 12,505 units · 871 per 100k residents HI Texas: 27,777 units · 91.1 per 100k residents TX Florida: 10,302 units · 45.6 per 100k residents FL
Units reimbursed · per 100k residents
45.611,938
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 Rhode Island 11,938 /100k
2 Kentucky 8,447 /100k
3 Nebraska 7,795 /100k
4 New Jersey 5,189 /100k
5 New York 4,961 /100k
6 Michigan 4,868 /100k
7 Delaware 4,838 /100k
8 Illinois 4,813 /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.
118 ml57237-0305-12 64,455 Rx · $292,680
473 ml this page57237-0305-16 50,158 Rx · $299,448
Drug total (last 4 qtrs): 114,613 Rx · 16,342,136 units · $592,128 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Diphenhydramine Oral Liquid (this brand).

Top reported reactions

Fatigue3,537
Headache3,168
Pain3,157
Infusion Related Reaction2,800
Nausea2,743
Arthralgia2,738
Nasopharyngitis2,435

Age at onset

Neonate40
Infant16
Child154
Adolescent239
Adult3,235
Elderly1,301

Reporter sex

21,243 reports
Male · 29%
Female · 71%
Unknown · 0%

Serious outcomes

Hospitalization7,635
Death3,664
Life-threatening1,232
Disabling828
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,442 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
57237-0305-12 118 mL in 1 BOTTLE (57237-305-12) $0.0196 / mL $2.31 2022-12-19 Active
57237-0305-16 You're viewing this 473 mL in 1 BOTTLE (57237-305-16) $0.0175 / mL $8.28 2022-12-19 Active

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

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.0175 NADAC).

This pack accounts for about 44% of this product's recent Medicaid fills; most go to the 118 ml pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 57237-0305-16?
NDC 57237-0305-16 contains 473 mL — 473 ml in 1 bottle.
What is the difference between NDC 57237-0305-16 and NDC 57237-0305-12?
Both are Diphenhydramine Oral Liquid Diphenhydramine Hydrochloride 12.5 mg/5mL Liquid — the drug itself is identical. NDC 57237-0305-16 is the 473 mL package, while NDC 57237-0305-12 is the 118 ml package. Per-mL NADAC also differs: $0.0175 here vs $0.0196 for the 118 ml pack.
What NDC number is used to bill for this package of Diphenhydramine Oral Liquid Diphenhydramine Hydrochloride 12.5 mg/5mL Liquid?
Bill NDC 57237-0305-16 — the 11-digit billing format is 57237030516. 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.

📄 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
🎯 Indications and Usage 38 words ▾

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

⏱️ Dosage and Administration 55 words ▾

Directions take every 4-6 hours Do not use more than 6 dose in 24 hours adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 to 50 mg) children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 to 25 mg) children under 6 years ask a doctor

⚠️ Warnings 178 words ▾

Warnings Do not use 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. a sodium-restricted diet 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. Directions take every 4-6 hours Do not use more than 6 dose in 24 hours adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 to 50 mg) children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 to 25 mg) children under 6 years ask a doctor

📦 Storage and Handling 42 words ▾

Other information store at room temperature 15º - 30ºC (59º - 86ºF) protect from freezing protect from light each teaspoon (5 mL) contains: sodium 8 mg TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

🧪 Active Ingredient 14 words ▾

Active ingredient in each 5 mL ( in one teaspoonful) Diphenhydramine HCl, 12.5 mg

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients cherry flavor, citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water. Questions or comments? 1-844-474-7464

🎯 Purpose 2 words ▾

Purpose Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 57237-0304-12 · Rising 57237-0310-54 · Rising →
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.