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Diphenhydramine HCl Oral Solution 12.5 mg/5mL Solution

by Rising Pharma Holdings, Inc. · 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-317-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-317-05)
NDC 57237-0317-51
🏷️ FDA NDC (as labeled) 57237-317-51 billing pads the product segment with a zero
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) 57237-317-51
Product NDC 57237-317
11-digit billing NDC 57237031751
NCPDP billing unit ML — per mL (volume)
RxCUI 1049906
UNII TC2D6JAD40
UPC 0357237317518
Application # M009.50
SPL Set ID 7406e4e4-3093-4cd1-80ce-93f7b6db2a87
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 2023-12-15
Route ORAL
Dosage form SOLUTION
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 12.5MG/5ML CUP
FDB brand name Diphenhydramine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 57237-317-51 — 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 → 57237-0317-51. 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 2023
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 12.5MG/5ML CUP Ingredient Diphenhydramine Hcl
📗 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.

🧪 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesInactive ingredients:  citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 —
Childrens Allergy 12.5 mg/5mL 63868-0823-54 QUALITY 1 bottle $0.016 — FDA listed —
Childrens Allergy Relief Dye Free 12.5 mg/5mL 70000-0693-01 CARDINAL 1 bottle $0.016 — Availability likely —
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 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 —
Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 24385-0379-26 Amerisource 1 bottle $0.020 — Availability likely —
Allergy Relief 50 mg/20mL 46122-0685-26 Amerisource 1 bottle $0.020 — Availability likely —
Good NeighborChildrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 46122-0793-29 AMERISOURCE 1 bottle $0.020 — Availability likely —
Diphenhydramine Oral Liquid 12.5 mg/5mL 57237-0305-12 Rising 118 ml $0.020 — Availability likely —
M-Dryl 12.5 mg/5mL 58657-0528-04 Method 120 ml $0.020 — Availability likely —
leader childrens allergy relief 12.5 mg/5mL 70000-0474-01 Cardinal 1 bottle $0.020 — Availability likely —
Childrens Allergy Relief 12.5 mg/5mL 70000-0701-01 Cardinal 1 bottle $0.020 — Availability likely —
foster and thrive childrens allergy relief 12.5 mg/5mL 70677-1268-01 Strategic 1 bottle $0.020 — Availability likely —
Diphenhydramine Hcl 12.5 Mg Per 5 Ml 12.5 mg/5mL 82568-0016-04 AARNA 118 ml $0.020 — Availability likely —
Foster and Thrive Childrens Allergy Relief 12.5 mg/5mL 70677-1012-01 Strategic 1 bottle $0.020 — Availability likely —
Quality Choice Dye Free Cherry Childrens Allergy Relief 12.5 mg/5mL 83324-0016-04 Chain 1 bottle $0.027 — FDA listed —
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/5mLthis 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 —
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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
57237-0317-51 You're viewing this 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-317-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-317-05) 2023-12-15 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 57237-317-51, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 57237-0317-51, written without dashes as 57237031751. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 57237-0317-51, the first segment (57237) is the labeler code FDA assigned to Rising Pharma Holdings, Inc.; the middle segment (0317) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (51) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Rising Pharma Holdings, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rising Pharma Holdings, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 30 words ▾

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

⏱️ Dosage and Administration 69 words ▾

Directions • take every 4 to 6 hours, or as directed by a physician • do not take more than 6 doses in 24 hours age dose Children under 2 years of age Do not use Children 2 to under 6 years of age Do not use unless directed by a doctor Children 6 to under 12 years of age 5 mL (12.5 mg) to 10 mL (25 mg)

⚠️ Warnings 102 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 the child has • a breathing problem such as chronic bronchitis • glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

🧪 Active Ingredient 12 words ▾

Active ingredient per 5 mL (1 Unit Dose) Diphenhydramine HCl 12.5 mg

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

🎯 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 ↗
← 57237-0316-31 · Rising 57237-0318-11 · 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.