Dimetane Diphenhydramine Hydrochloride 50 mg Capsule, Liquid Filled, 1,000-count — NDC 57237-0368-99 package photo

Dimetane Diphenhydramine Hydrochloride 50 mg Capsule, Liquid Filled, 1,000-count

by Rising Pharma Holdings, Inc. · 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-368-99)
NDC 57237-0368-99
🏷️ FDA NDC (as labeled) 57237-368-99 billing pads the product segment with a zero
This package
Contains1,000-count Cost per ea$0.0313 NADAC Per package$31.30 / 1000 capsules Pack sizes2 compare ↓
OTC On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 57237-368-99
Product NDC 57237-368
11-digit billing NDC 57237036899
NCPDP billing unit EA — each (per item)
RxCUI 1020477, 1049909
UNII 8GTS82S83M, TC2D6JAD40
UPC 0357237368992
Application # M012
SPL Set ID 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f
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 2026-01-27
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIPHENHYDRAMINE
GPI-14 41200030100110
GCN Seq No 011583
GCN 45972
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 DIMETANE 50 MG SOFTGEL
FDB brand name Dimetane
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 57237-368-99 — 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 → 57237-0368-99. 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 applicationM012 (OTC MONOGRAPH DRUG)
Labeler code57237
First marketedJan 2026
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 DIMETANE 50 MG SOFTGEL 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 →
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 white / blue
ShapeOval
ImprintBZ9
Size13 mm
ScoringNot scored
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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6O92ICV9RU
    A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
  • 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.

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

The official label also states25mg:-  Gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution 50mg:-  FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol sorbitan 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 DailyMedingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $0.031 $31.30 / 1000 capsules
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.
NADAC price history (per ea) — tap or hover for the price & month
May 2026 Jun 2026 Jul 2026 Aug 2026 $0.032 $0.024
▲ Up 28% over the last 4 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
Diphenhydramine Hydrochloride 50 mg 42806-0649-10 Epic 1000 capsules $0.020 FDA listed save 35%
Diphenhydramine Hydrochloride 50 mg 00904-2056-61 Major 100 capsules $0.031 Availability likely
Banophen 50 mg 00904-5307-60 Major 100 capsules $0.031 Discontinued
Dimetane 50 mgthis 57237-0368-99 Rising 1000 capsules $0.031 Availability likely
Diphenhydramine HCl 50 mg 82568-0005-01 AARNA 100 capsules $0.031 Availability likely
Nighttime Sleep Aid Maximum Strength 50 mg 62011-0416-01 Strategic 32 capsules $0.095 FDA listed +204%
Nighttime Sleep Aid maximum strength 50 mg 70000-0527-01 Cardinal 32 capsules $0.104 Availability likely +234%
Nighttime Sleep-Aid 50 mg 46122-0775-64 AMERISOURCE 60 capsules $0.117 Availability likely +274%
Nighttime Sleep Aid 50 mg 70000-0616-01 Cardinal 100 capsules $0.117 Availability likely +274%
Sleep Aid 50 mg 70677-1151-01 Strategic 32 capsules $0.117 Availability likely +274%
Sleep Aid 50 mg 83324-0151-32 QUALITY 32 capsules $0.117 Availability likely +274%
Wal Som Nighttime Sleep Aid 50 mg 00363-0816-16 Walgreens 160 capsules FDA listed
Wal Som Nighttime Sleep Aid Nighttime 50 mg 00363-0860-16 Walgreens 160 capsules FDA listed
Allergy Relief 50 mg 00363-6123-20 WALGREEN 100 capsules FDA listed
Sleep Aid 50 mg 11673-0360-32 TARGET 32 capsules FDA listed
Pharbedryl 50 mg 16103-0347-08 Pharbest 100 capsules FDA listed
Diphenhydramine Hydrochloride 50 mg 17714-0021-01 Advance 100 capsules FDA listed
Sleep Aid 50 mg 21130-0052-32 Better 32 capsules FDA listed
Sleep Aid 50 mg 21130-0816-32 Safeway, 32 capsules FDA listed
Sleep Aid 50 mg 21130-0860-32 Safeway, 32 capsules FDA listed
SleepAid (Diphenhydramine HCL) 50 mg 24689-0154-01 APNAR 100 capsules FDA listed
Kroger Nighttime Sleep-Aid 50 mg 30142-0558-64 THE 64 capsules FDA listed
Nighttime Sleep-Aid 50 mg 30142-0681-18 KROGER 64 capsules FDA listed
Sleep Aid 50 mg 30142-0715-32 The 32 capsules FDA listed
Diphenhydramine Hydrochloride 50 mg 35916-0438-01 SOFTGEL 100 capsules FDA listed
Diphenhydramine Hydrochloride 50 mg 35916-0470-01 Softgel 1000 capsules FDA listed
Diphenhydramine hydrochloride 50 mg 35916-0472-01 Softgel 1000 capsules FDA listed
Nighttime Sleep Aid 50 mg 36800-0116-32 TOP 32 capsules FDA listed
Sleep Aid Maximum Strength 50 mg 37808-0860-12 H 120 capsules FDA listed
Sleep Aid Nighttime 50 mg 41163-0860-32 United 32 capsules FDA listed
Unisom SleepGels Nighttime Sleep-Aid 50 mg 41167-0061-00 Chattem, 8 capsules Discontinued
Nighttime Sleep-Aid 50 mg 42681-0051-01 Whole 32 capsules FDA listed
Nighttime sleep aid 50 mg 42829-0950-20 ASCENT 120 capsules Discontinued
Sleep Aid 50 mg 49035-0736-10 EQUATE 100 capsules FDA listed
Benadryl Allergy Extra Strength Liqui-Gels 50 mg 50580-0322-20 Kenvue 10 capsules FDA listed
Sleep Aid 50 mg 50804-0410-38 Good 32 capsules FDA listed
Nighttime Sleep Aid 50 mg 50804-0860-32 Good 32 capsules FDA listed
Nighttime SLEEP AID 50 mg 51013-0817-01 PuraCap 100 capsules FDA listed
Diphenhydramine Hydrochloride 50 mg 53345-0005-01 Humanwell 12000 capsules FDA listed
Diphenhydramine Hydrochloride 50 mg 53345-0022-01 Humanwell 12000 capsules FDA listed
Nighttime Sleep-Aid 50 mg 53943-0485-18 DISCOUNT 64 capsules FDA listed
Discount Drugmart Nighttime Sleep-Aid 50 mg 53943-0822-64 Discount 64 capsules FDA listed
Diphenhydramine Hydrochloride 50 mg 54738-0116-01 Richmond 100 capsules FDA listed
Diphenhydramine HCl 50 mg 55154-0661-00 Cardinal 10 capsules FDA listed
Sleep Aid 50 mg 55319-0564-32 Family 32 capsules FDA listed
Sleep Aid 50 mg 55910-0798-16 Dolgencorp, 16 capsules FDA listed
Sleep Aid 50 mg 55910-0894-16 Dolgencorp, 16 capsules FDA listed
Sleep Aid Nighttime 50 mg 55910-0916-16 Dolgencorp, 16 capsules FDA listed
Sleep Aid Maximum Strength 50 mg 59726-0760-64 P 64 capsules FDA listed
Sleep Aid Maximum Strength 50 mg 59726-0816-64 P 64 capsules FDA listed
Nighttime Sleep Aid 50 mg 59726-0916-32 P 32 capsules FDA listed
Diphenhydramine HCL 50 mg 63187-0866-10 Proficient 10 capsules FDA listed
Banophen 50 mg 63629-9451-01 Bryant 30 capsules FDA listed
Sleep Aid Maximum Strength 50 mg 63868-0415-32 QUALITY 32 capsules FDA listed
Sleep Aid Maximum Strength 50 mg 63868-0900-32 QUALITY 32 capsules FDA listed
Nighttime Sleep-Aid 50 mg 63941-0604-17 VALU 60 capsules FDA listed
Nighttime Sleep-Aid 50 mg 63941-0683-17 VALU 60 capsules FDA listed
Nighttime sleep aid Maximum Strength 50 mg 63941-0860-16 Best 1 capsule FDA listed
Nighttime sleep aid Maximum Strength 50 mg 63941-0916-16 Best 1 capsule FDA listed
Diphenhydramine HCL 50 mg 66267-0081-30 NuCare 30 capsules FDA listed
Diphenhydramine HCL 50 mg 66267-0779-06 NuCare 6 capsules FDA listed
Diphenhydramine HCL 50 mg 66424-0021-01 SDA 100 capsules FDA listed
Sleep Aid Maximum Strength 50 mg 67091-0413-32 WinCo 32 capsules FDA listed
Nighttime Sleep Aid 50 mg 68210-4160-08 Prodose, 8 capsules FDA listed
Diphenhydramine Hydrochloride 50 mg 68210-5057-01 Prodose, 3000 capsules FDA listed
Banophen 50 mg 68788-7830-01 Preferred 15 capsules FDA listed
Diphenhydramine HCL 50 mg 68788-9688-01 Preferred 15 capsules FDA listed
Sleep Aid 50 mg 69168-0410-03 Allegiant 250 capsules FDA listed
Sleep Aid 50 mg 69168-0917-40 Allegiant 32 capsules FDA listed
Sleep Aid Maximum Strength 50 mg 69256-0860-32 Harris 32 capsules FDA listed
Nighttime Sleep Aid Maximum Strength 50 mg 69256-0916-32 Harris 32 capsules FDA listed
nighttime sleep-aid 50 mg 69452-0322-79 Bionpharma 160 capsules FDA listed
Nighttime Sleep-Aid 50 mg 69452-0427-10 BIONPHARMA 32 capsules FDA listed
Nighttime Sleep-Aid 50 mg 69452-0451-22 BIONPHARMA 120 capsules FDA listed
Allergy Relief 50 mg 69452-0452-20 BIONPHARMA 100 capsules FDA listed
Nighttime Sleep Aid 50 mg 69607-0916-06 WR 96 capsules FDA listed
Sleep Aid Nighttime 50 mg 69842-0860-32 CVS 32 capsules FDA listed
Sleep Aid Nighttime 50 mg 69842-0916-32 CVS 32 capsules FDA listed
Diphenhydramine Hydrochloride 50 mg 70692-0785-61 Strive 16 capsules FDA listed
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel 50 mg 70692-0834-71 Strive 275 capsules FDA listed
Banophen 50 mg 71335-0081-00 Bryant 12 capsules FDA listed
Diphenhydramine HCl 50 mg 71399-1028-01 Akron 100 capsules FDA listed
SleepAid Softgels 50 mg 72090-0023-01 PIONEER 180 capsules FDA listed
Nighttime Sleep Aid 50 mg 72476-0860-32 Care 32 capsules FDA listed
Nighttime Sleep Aid Maximum Strength 50 mg 72476-0916-32 Care 32 capsules FDA listed
Diphenhydramine HCL 50 mg 72789-0532-20 PD-Rx 20 capsules FDA listed
Pharbedryl 50 mg 73057-0347-08 Ulai 100 capsules FDA listed
Allergy Relief Diphenhydramine HCL 50 MG 73581-0020-10 YYBA 1000 capsules FDA listed
DIPHENHYDRAMINE HYDROCHLORIDE 50mg 50 mg 73629-0001-22 AMZ789 220 capsules FDA listed
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid 50 mg 76162-0438-96 Topco 96 capsules FDA listed
Nightime Sleep Aid 50 mg 76168-0065-37 Velocity 1 capsule FDA listed
Antihistamine 50 mg 77333-0231-10 Gendose 100 capsules FDA listed
Sleep Aid 50 mg 81522-0916-32 FSA 32 capsules FDA listed
Sleep Aid 50 mg 82442-0530-32 TARGET 32 capsules FDA listed
Nighttime Sleep Aid 50 mg 83059-0028-08 Shield 8 capsules Discontinued
Nighttime Sleep Aid 50 mg 83059-0109-08 Shield 8 capsules Discontinued
SleepAid Softgels 50 mg 84324-0011-01 NUVICARE 100 capsules FDA listed
Nighttime Sleep Aid 50 mg 85828-0410-38 Grocery 32 capsules 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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Per unit Per pack Marketing startStatus
57237-0368-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-368-01) $0.0313 / ea $3.13 2026-01-27 Active
57237-0368-99 You're viewing this 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-368-99) $0.0313 / ea $31.31 2026-01-27 Active

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

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0313 NADAC).

Pack size FAQ

What quantity is in NDC 57237-0368-99?
NDC 57237-0368-99 is a 1,000-count package — 1000 capsule, liquid filled in 1 bottle.
What is the difference between NDC 57237-0368-99 and NDC 57237-0368-01?
Both are Dimetane Diphenhydramine Hydrochloride 50 mg Capsule, Liquid Filled — the drug itself is identical. NDC 57237-0368-99 is the 1,000-count package, while NDC 57237-0368-01 is the 100 capsules package.
What NDC number is used to bill for this package of Dimetane Diphenhydramine Hydrochloride 50 mg Capsule, Liquid Filled?
Bill NDC 57237-0368-99 — the 11-digit billing format is 57237036899. 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 26 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

⏱️ Dosage and Administration 39 words

Directions take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours adults and children 12 years and over 1 softgel children under 12 years do not use

⚠️ Warnings 126 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. (1-800-222-1222)

📦 Storage and Handling 35 words

Other Information Store between 20-25°C (68-77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) Protect from moisture and light. Tamper Evident: do not use if foil seal under cap is broken or missing.

🧪 Active Ingredient 12 words

Active Ingredient (in each softgel) Diphenhydramine HCl 25 mg & 50 mg

🧪 Inactive Ingredients 30 words

Inactive Ingredients 25mg:- Gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution 50mg:- FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol sorbitan solution

🎯 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 ↗
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.