FDA.reportPublic FDA data

Dimetane

Manufacturer
Rising Pharma Holdings, Inc.
Effective date
2026-01-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:25

Label at a glance#

ProductDimetane
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE
Label structure10 sections

Indications and 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

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 

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg & 50 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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)

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 

Other Information

STORAGE AND HANDLING SECTION

  • 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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

57237-367-99 Dimetane label fig-157237-367-99 Dimetane label fig-1

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

57237-368-99 Dimetane labels fig-257237-368-99 Dimetane labels fig-2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN1
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD1
1020477diphenhydramine HCl 50 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357237368992GTIN-13: 0357237368992
EAN-13: 0357237368992
GTIN-12: 357237368992
UPC-A: 357237368992
GTIN storage (14 digits): 00357237368992		57237-368-99 Dimetane labels fig-2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-367-01Dimetane100 in 1 BOTTLECAPSULE, LIQUID FILLED1001
57237-367-99Dimetane1000 in 1 BOTTLECAPSULE, LIQUID FILLED10001
57237-368-01Dimetane100 in 1 BOTTLECAPSULE, LIQUID FILLED1001
57237-368-99Dimetane1000 in 1 BOTTLECAPSULE, LIQUID FILLED10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-367-01EA - Each57237-367e5cbb116-bb64-4ac1-b056-693aaf67837712026-02-05
57237-367-99EA - Each57237-36752918ffe-99b2-4ea2-b110-01ee01c5a25c12026-02-05
57237-368-01EA - Each57237-36862baf022-bbe0-43a6-bcdb-9b2d3e9c6daf12026-02-05
57237-368-99EA - Each57237-36876cfcca6-6cfb-4b60-bdf6-be4ef61ca11712026-02-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-36757237-367-01, 57237-367-99
57237-36857237-368-01, 57237-368-99

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
DIPHENHYDRAMINE8GTS82S83MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DimetaneDIPHENHYDRAMINE HYDROCHLORIDERising Pharma Holdings, Inc.484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f2026-01-19WarningsExact identifier
ndc (package): 57237-368-01
ndc (package): 57237-368-99
ndc (package): 57237-367-01
ndc (package): 57237-367-99
ndc (product): 57237-368
ndc (product): 57237-367
ndc11 (package): 57237036801
ndc11 (package): 57237036701
ndc11 (package): 57237036899
ndc11 (package): 57237036799
spl id: 958e9dae-4d1c-40fc-b84d-20f2ed6996c0
spl set id: 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.