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DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Capsule, Liquid Filled, 3-count — NDC 35916-0435-01 package photo

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Capsule, Liquid Filled, 3-count

by SOFTGEL HEALTHCARE PRIVATE LIMITED · 3 CAPSULE, LIQUID FILLED in 1 CARTON (35916-0435-1)
NDC 35916-0435-01
🏷️ FDA NDC (as labeled) 35916-0435-1 billing pads the package segment with a zero
This package
Contains3-count Pack sizes4 compare ↓
Also comes in: 1000 capsules 35916-0435-03 1500 capsules 35916-0435-05 3000 capsules 35916-0435-04
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) 35916-0435-1
Product NDC 35916-0435
11-digit billing NDC 35916043501
RxCUI 1049909
UNII TC2D6JAD40
Application # M012
SPL Set ID 0203d919-dc1f-cca0-e063-6394a90aa1aa
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 2023-08-07
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 35916-0435-1 — a 5-4-1 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 package segment → 35916-0435-01. 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.

🏭 Manufacturer & labeler

LabelerSOFTGEL HEALTHCARE PRIVATE LIMITED
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code35916
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio23 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

📖 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 white
ShapeCapsule
Size15 mm
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 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 statesgelatin, glycerin, polyethylene glycol 400, propylene glycol, 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.

💲 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.
Try another pack size: 1000 capsules 1500 capsules 3000 capsules
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 25 mg 42806-0648-10 Epic 1000 capsules $0.034 — FDA listed —
Allergy Relief 25 mg 63868-0087-01 Chain 100 capsules $0.034 — FDA listed —
Diphenhydramine Hydrochloride 25 mg 00904-7237-24 Major 24 capsules $0.054 — Availability likely —
Allergy Relief 25 mg 46122-0440-62 Amerisource 24 capsules $0.054 — Availability likely —
Good Neighbor Allergy Relief 25 mg 46122-0699-62 AmerisourceBergen 12 capsules $0.054 — Availability likely —
Allergy Relief 25 mg 46122-0828-51 AMERISOURCE 12 capsules $0.054 — Availability likely —
Dimetane 25 mg 57237-0367-01 Rising 100 capsules $0.054 — Availability likely —
Allergy Relief Diphenhydramine HCl 25 mg 70000-0585-01 Cardinal 12 capsules $0.054 — Availability likely —
Diphenhydramine Hydrochloride 25 mg 70000-0598-01 LEADER/ 24 capsules $0.054 — Availability likely —
Allergy Relief 25 mg 70677-1015-01 Strategic 24 capsules $0.054 — Availability likely —
Diphenhydramine HCl 25 mg 82568-0004-01 AARNA 100 capsules $0.054 — Availability likely —
Allergy Relief 25 mg 83324-0087-01 CHAIN 100 capsules $0.054 — Availability likely —
Quality Choice Allergy Relief 25 mg 83324-0118-24 Chain 12 capsules $0.054 — Availability likely —
Allergy Relief 25 mg 83324-0280-24 CHAIN 12 capsules $0.054 — Availability likely —
Sleep-Aid Diphenhydramine HCl 25 mg 70000-0584-01 Cardinal 12 capsules $0.221 — Availability likely —
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 — — FDA listed —
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 mgthis 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 — — FDA listed —
Pharbedryl 25 mg 60760-0699-30 St. 30 capsules — — FDA listed —
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

🏛️
2023
On the market since
Aug 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.

🔬 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 HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Fatigue16,399
Nausea14,606
Headache14,003
Pain11,969
Dyspnoea11,085
Pruritus10,525
Infusion Related Reaction9,947

Age at onset

Neonate106
Infant195
Child1,828
Adolescent1,476
Adult20,867
Elderly9,044

Reporter sex

171,992 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization49,087
Life-threatening7,190
Disabling3,673
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13,771 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 Marketing startStatus
35916-0435-01 You're viewing this 3 CAPSULE, LIQUID FILLED in 1 CARTON (35916-0435-1) 2023-08-07 Active
35916-0435-03 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0435-3) 2025-04-22 Active
35916-0435-04 2 POUCH in 1 BOX (35916-0435-4) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH 2025-06-11 Active
35916-0435-05 2 BAG in 1 BOX (35916-0435-5) / 1500 CAPSULE, LIQUID FILLED in 1 BAG 2026-01-24 Active

Pack size FAQ

What quantity is in NDC 35916-0435-01?
NDC 35916-0435-01 is a 3-count package — 3 capsule, liquid filled in 1 carton.
What is the difference between NDC 35916-0435-01 and NDC 35916-0435-03?
Both are DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Capsule, Liquid Filled — the drug itself is identical. NDC 35916-0435-01 is the 3-count package, while NDC 35916-0435-03 is the 1000 capsules package.
What NDC number is used to bill for this package of DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Capsule, Liquid Filled?
Bill NDC 35916-0435-01 — the 11-digit billing format is 35916043501. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
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 35916-0435-1, 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: 35916-0435-01, written without dashes as 35916043501. 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 35916-0435-01, the first segment (35916) is the labeler code FDA assigned to SOFTGEL HEALTHCARE PRIVATE LIMITED; the middle segment (0435) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 SOFTGEL HEALTHCARE PRIVATE LIMITED. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1000 capsules (35916-0435-03), 1500 capsules (35916-0435-05), 3000 capsules (35916-0435-04). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
SOFTGEL HEALTHCARE PRIVATE LIMITED 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 📦 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 52 words ▾

Directions take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use this product in children under 6 years of age

⚠️ Warnings 19 words ▾

Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin

📦 Storage and Handling 19 words ▾

Other Information store between 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.

🧪 Active Ingredient 9 words ▾

Active ingredient (in each softgel) Diphenhydramine Hydrochloride USP 25mg

🧪 Inactive Ingredients 14 words ▾

Inactive Ingredients gelatin, glycerin, polyethylene glycol 400, propylene glycol, 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 ↗
← 35916-0423-01 · SOFTGEL 35916-0436-02 · SOFTGEL →
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