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Dimetane Diphenhydramine Hydrochloride 25 mg Capsule, Liquid Filled, 100-count — NDC 57237-0367-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dimetane Diphenhydramine Hydrochloride 25 mg Capsule, Liquid Filled, 100-count — NDC 57237-367-01 (Billing 57237-0367-01)

by Rising Pharma Holdings, Inc. · 100 CAPSULE, LIQUID FILLED in 1 BOTTLE

This is a package of 100 capsules of Dimetane Diphenhydramine Hydrochloride 25 mg Capsule, Liquid Filled from Rising Pharma Holdings, Inc., marketed since Jan 2026 and currently FDA-listed; retail pharmacies pay about $0.0534 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 57237-0367-01
🏷️ FDA NDC (as labeled) 57237-367-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0534 NADAC Per package$5.34 / 100 capsules Pack sizes2 compare ↓
Main listing for product 57237-367 · Also comes in: 1000 capsules 57237-367-99
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 57237-367-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
57237 labeler · 367 product · 01 package
Package marketed since
Jan 27, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
100 EA per package
Barcode (UPC)
0357237368992
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57237-367-01
Product NDC 57237-367
11-digit billing NDC 57237036701
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 HYDROCHLORIDE

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

GPI-14 41200030100105
GCN Seq No 011582
GCN 45971
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 25 MG SOFTGEL
FDB brand name Dimetane
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 011582
  • GCN: 45971
  • GPI-14 (Medi-Span): 41200030100105
  • HICL (First Databank): 004480
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 1020477
Why two NDCs? The FDA registers this code as 57237-367-01 — 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 → 57237-0367-01. 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 DIMETANE 25 MG SOFTGEL Ingredient Diphenhydramine Hcl
📗 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 eaPer package
Retail pharmacies payNADAC · weekly $0.053 $5.34 / 100 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 Sep 2026 $0.060 $0.053
▼ Down 12% over the last 5 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
57237-0367-01 You're viewing this Main listing 100 CAPSULE, LIQUID FILLED in 1 BOTTLE $0.0534 / ea $5.34 2026-01-27 — Active
57237-0367-99 57237-367-99 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE $0.0534 / ea $53.36 2026-01-27 — Active

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

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0534 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule, liquid filled in 1 bottle.
How does this package differ from NDC 57237-0367-99?
Both are Dimetane Diphenhydramine Hydrochloride 25 mg Capsule, Liquid Filled — the drug itself is identical. This page's package is the 100-count one, while NDC 57237-0367-99 is the 1000 capsules package.
What NDC number is used to bill for this package of Dimetane Diphenhydramine Hydrochloride 25 mg Capsule, Liquid Filled?
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
Diphenhydramine Hydrochloride 25 mg 42806-0648-10 Epic 1000 capsules $0.034 — FDA listed save 37%
Allergy Relief 25 mg 63868-0087-01 Chain 100 capsules $0.034 — FDA listed save 37%
Diphenhydramine Hydrochloride 25 mg 00904-7237-24 Major 24 capsules $0.053 — Availability likely —
Allergy Relief 25 mg 46122-0440-62 Amerisource 24 capsules $0.053 — Availability likely —
Good Neighbor Allergy Relief 25 mg 46122-0699-62 AmerisourceBergen 12 capsules $0.053 — Availability likely —
Allergy Relief 25 mg 46122-0828-51 AMERISOURCE 12 capsules $0.053 — Availability likely —
Dimetane 25 mgthis 57237-0367-01 Rising 100 capsules $0.053 — Availability likely —
Allergy Relief Diphenhydramine HCl 25 mg 70000-0585-01 Cardinal 12 capsules $0.053 — Availability likely —
Diphenhydramine Hydrochloride 25 mg 70000-0598-01 LEADER/ 24 capsules $0.053 — Availability likely —
Allergy Relief 25 mg 70677-1015-01 Strategic 24 capsules $0.053 — Availability likely —
Diphenhydramine HCl 25 mg 82568-0004-01 AARNA 100 capsules $0.053 — Availability likely —
Allergy Relief 25 mg 83324-0087-01 CHAIN 100 capsules $0.053 — Availability likely —
Quality Choice Allergy Relief 25 mg 83324-0118-24 Chain 12 capsules $0.053 — Availability likely —
Allergy Relief 25 mg 83324-0280-24 CHAIN 12 capsules $0.053 — Availability likely —
Sleep-Aid Diphenhydramine HCl 25 mg 70000-0584-01 Cardinal 12 capsules $0.215 — Availability likely +304%
Free and Pure Allergy Relief Dye Free 25 mg 00363-1175-24 WALGREEN 12 capsules — — FDA listed —
Allergy Relief 25 mg 00363-1900-08 Walgreen 24 capsules — — FDA listed —
Sleep Aid 25 mg 00363-6130-24 WALGREENS 24 capsules — — FDA listed —
Allergy Relief Dye Free 25 mg 00363-6682-24 Walgreens 12 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 00363-8350-02 Walgreen 600 capsules — — FDA listed —
Nighttime Sleep Aid 25 mg 00363-8989-12 WALGREEN 12 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 00363-9835-01 Walgreen 100 capsules — — Discontinued —
Nighttime Sleep Aid 25 mg 11673-0703-24 TARGET 12 capsules — — FDA listed —
Allergy Relief 25 mg 11822-0190-01 Rite 100 capsules — — FDA listed —
Pharbedryl 25 mg 16103-0348-03 Pharbest 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 17714-0020-01 Advance 100 capsules — — FDA listed —
Kroger Allergy Relief 25 mg 30142-0554-24 THE 12 capsules — — FDA listed —
Allergy Antihistamine 25 mg 30142-0832-48 KROGER 48 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 35916-0435-01 SOFTGEL 3 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 35916-0436-02 SOFTGEL 1000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 35916-0471-01 SOFTGEL 1000 capsules — — FDA listed —
TopCare Allergy Relief 25 mg 36800-0367-24 TOPCO 12 capsules — — FDA listed —
Allergy Relief 25 mg 36800-0910-01 TopCo 24 capsules — — FDA listed —
ZzzQuil Nighttime Sleep-Aid 25 mg 37000-0501-08 The 2 capsules — — FDA listed —
Allergy Medicine 25 mg 37835-0647-01 Bi-Mart 100 capsules — — FDA listed —
Allergy Relief 25 mg 41163-0613-03 United 100 capsules — — FDA listed —
Unisom SleepMinis Nighttime Sleep-Aid 25 mg 41167-0067-00 Chattem, 60 capsules — — FDA listed —
EZ Nite Sleep 25 mg 41226-0613-24 KROGER 12 capsules — — FDA listed —
Allergy Relief 25 mg 41520-0996-04 FOODHOLD 12 capsules — — FDA listed —
Allergy Relief 25 mg 42507-0313-01 HYVEE 24 capsules — — FDA listed —
Allergy Relief 25 mg 42681-0050-01 Whole 30 capsules — — FDA listed —
Nighttime sleep aid 25 mg 42829-0925-20 ASCENT 120 capsules — — Discontinued —
Allergy Relief 25 mg 49035-0901-08 Wal-Mart 24 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 50090-5716-00 A-S 30 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 50090-5744-01 A-S 28 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 50090-7014-00 A-S 100 capsules — — FDA listed —
Benadryl Allergy Liqui-Gels 25 mg 50580-0228-24 Kenvue 12 capsules — — FDA listed —
Allergy Relief 25 mg 50804-0091-08 Geiss, 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 51316-0347-05 CVS 120 capsules — — FDA listed —
Allergy Relief mini Softgels 25 mg 51316-0687-36 CVS 365 capsules — — FDA listed —
Nighttime Sleep-Aid Softgel 25 mg 51316-0779-24 CVS 12 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 51316-0835-01 CVS 100 capsules — — FDA listed —
Allergy Relief Dye-Free Softgel 25 mg 51316-0998-22 CVS 12 capsules — — FDA listed —
Diphenhydramine HYDROCHLORIDE 25 mg 51662-1628-01 HF 2 capsules — — FDA listed —
Dormin 25 mg 52412-0100-02 Randob 2 capsules — — Discontinued —
Diphenhydramine Hydrochloride 25 mg 53345-0002-02 Humanwell 20000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 53345-0007-01 Humanwell 20000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 53345-0027-01 Humanwell 20000 capsules — — FDA listed —
Allergy 25 mg 53943-0113-01 DISCOUNT 24 capsules — — FDA listed —
Discount Drugmart Allergy Relief 25 mg 53943-0821-24 Discount 12 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 54738-0115-13 Richmond 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 55154-2344-00 Cardinal 10 capsules — — FDA listed —
Diphenhydramine HCl 25 mg 55289-0479-10 PD-Rx 10 capsules — — FDA listed —
Allergy Relief 25 mg 55301-0190-08 ARMY 24 capsules — — FDA listed —
Allergy Relief 25 mg 55910-0191-08 DOLGENCORP, 24 capsules — — FDA listed —
Allergy Relief 25 mg 55910-0752-09 DOLGENCORP 12 capsules — — FDA listed —
Complete Allergy Medicine 25 mg 57243-0190-08 Salado 24 capsules — — FDA listed —
Allergy Relief 25 mg 59640-0090-12 HEB 12 capsules — — FDA listed —
Allergy Relief 25 mg 59779-0019-22 CVS 48 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 60760-0697-30 St. 30 capsules — — Discontinued —
Pharbedryl 25 mg 60760-0699-30 St. 30 capsules — — Discontinued —
Quality Choice Nighttime Sleep-Aid 25 mg 63868-0970-24 Chain 12 capsules — — FDA listed —
Allergy Relief 25 mg 63941-0413-01 VALU 24 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 66424-0020-01 SDA 100 capsules — — FDA listed —
ZzzQuil 50 mg/21 66715-9746-01 Lil' 2 capsules — — FDA listed —
Allergy Relief Complete 25 mg 67091-0201-24 WinCo 24 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 68071-3352-04 NuCare 4 capsules — — FDA listed —
Diphenhydramine HCl 25 mg 68071-3877-03 NuCare 30 capsules — — FDA listed —
Nighttime Sleep Aid 25 mg 68391-0613-92 BJWC 12 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 68788-8855-00 Preferred 10 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 68788-9687-00 Preferred 10 capsules — — FDA listed —
Allergy Relief 25 mg 68998-0113-01 Marc 24 capsules — — FDA listed —
Allergy DyeFree 25 mg 69168-0409-86 Allegiant 12 capsules — — FDA listed —
Sleep Aid 25 mg 69168-0431-86 Allegiant 12 capsules — — FDA listed —
Allergy Relief 25 mg 69452-0453-09 BIONPHARMA 12 capsules — — FDA listed —
Diphenhydramine HCl 25 mg 69618-0024-01 Reliable 100 capsules — — FDA listed —
Diphenhydramine HCl 25 mg 69842-0537-11 CVS 60 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 69842-0825-00 CVS 24 capsules — — FDA listed —
GOOD REMEDIES Allergy Relief SOFTGEL 25 mg 70692-0078-22 Strive 12 capsules — — FDA listed —
RIGHT REMEDIES Allergy Relief 25 mg 70692-0832-11 Strive 1000 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 71205-0615-30 Proficient 30 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 71335-0352-00 Bryant 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 71335-2257-00 Bryant 100 capsules — — FDA listed —
Diphenhydramine HCl 25 mg 71399-1027-01 Akron 100 capsules — — FDA listed —
Allergy Relief 25 mg 72036-0113-01 Harris 24 capsules — — FDA listed —
Harris Teeter Allergy Relief 25 mg 72036-0521-24 Harris 12 capsules — — FDA listed —
Allergy Relief Diphenhydramine HCl 25mg SoftGel 25 mg 72090-0052-01 Pioneer 100 capsules — — FDA listed —
Allergy Relief 25 mg 72476-0113-01 RETAIL 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 72789-0317-10 PD-Rx 10 capsules — — FDA listed —
Allergy Relief 25 mg 73057-0348-03 Ulai 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 73629-0007-22 AMZ789 220 capsules — — FDA listed —
Sleep Aid 25 mg 76162-0911-12 Company 12 capsules — — FDA listed —
Dye Free Allergy Relief 25 mg 76162-0914-24 Topco 12 capsules — — FDA listed —
Antihistamine 25 mg 77333-0227-10 Gendose 100 capsules — — FDA listed —
meijer NIGHTTIME Sleep Aid SOFTGEL 25 mg 79481-0779-04 Meijer, 12 capsules — — FDA listed —
Allergy Relief 25 mg 79481-0880-01 Meijer 12 capsules — — FDA listed —
Allergy Relief Dye Free 25 mg 79903-0057-24 Wal-Mart 12 capsules — — FDA listed —
Nighttime Sleep Aid 25 mg 79903-0083-01 Wal-Mart 12 capsules — — FDA listed —
Allergy Relief Dye Free 25 mg 79903-0193-48 Wal-Mart 12 capsules — — FDA listed —
Allergy Relief 25 mg 79903-0310-24 Walmart 12 capsules — — FDA listed —
equate NIGHTTIME Sleep-Aid 25 mg 79903-0400-12 WALMART 12 capsules — — FDA listed —
AXIV - VroZzz 25 mg 82706-0014-01 Vivunt 12 capsules — — FDA listed —
AXIV Allergy 25 mg 82706-0019-01 VIVUNT 12 capsules — — FDA listed —
Sleep Aid 25 mg 83059-0022-01 Shield 12 capsules — — Discontinued —
ValuRx Dye Free Allergy Relief 25 mg 83059-0080-01 Shield 12 capsules — — Discontinued —
ValuRx Dye Free Allergy Relief 25 mg 83059-0081-01 Shield 12 capsules — — Discontinued —
Sleep Aid 25 mg 83059-0115-08 Shield 8 capsules — — Discontinued —
Allergy Relief Diphenhydramine HCl 25mg SoftGel 25 mg 84324-0029-01 NUVICARE 60 capsules — — FDA listed —
Nighttime Sleep Aid 25 mg 00363-1174-24 WALGREEN 12 capsules — — FDA listed —
Sleep Aid 25 mg 83059-0075-08 Shield 8 capsules — — FDA listed —
Allergy Relief 25 mg 70000-0771-01 CARDINAL 100 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.

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.

🧪 Avoiding an ingredient? See Diphenhydramine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 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 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 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.

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 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

LabelerRising Pharma Holdings, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code57237
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio525 products on file

More NDCs from Rising Pharma Holdings, Inc. labeler code 57237

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 📄 Do Not Use 📄 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: 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

📄 Do Not Use 19 words ▾

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 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 10 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. (1-800-222-1222)

📄 Questions or Comments 53 words ▾

Questions or comments Call 1-877-474-7464 † This product is neither manufactured nor distributed by the owner of the registered trademark Benadryl ® and Liqui-Gels ® DIMETANE TM is a trademark owned by Rising Pharma Holdings, Inc. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India Mfg. Lic. No.: 10/UA/2016

📄 Package Label / Principal Display Panel 90 words ▾

PRINCIPAL DISPLAY PANEL NDC 57237-367-99 Dimetane TM Diphenhydramine HCl 25 mg Allergy Relief Antihistamine Compare to the active ingredient in Benadryl ® Allergy Liqui-Gels ®† For the Temporary Relief of Runny Nose Itchy, watery eyes, Sneezing, Itchy throat or nose NDC 57237-368-99 Dimetane TM Diphenhydramine HCl 50 mg Allergy Relief Extra Strength Antihistamine Compare to the active ingredient in Benadryl ® Allergy Liqui-Gels ®* Extra Strength ®† For the Temporary Relief of Runny Nose Itchy, watery eyes, Sneezing, Itchy throat or nose 57237-367-99 Dimetane label fig-1 57237-368-99 Dimetane labels fig-2

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

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 Dimetane (this brand).

Top reported reactions

Fatigue3,538
Headache3,168
Pain3,158
Infusion Related Reaction2,800
Nausea2,743
Arthralgia2,740
Nasopharyngitis2,435

Age at onset

Neonate40
Infant16
Child154
Adolescent240
Adult3,237
Elderly1,302

Reporter sex

21,290 reports
Male · 29%
Female · 71%
Unknown · 0%

Serious outcomes

Hospitalization7,670
Disabling829
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 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.
← 57237-0361-01 · Rising 57237-0368-01 · 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.