FDA.reportPublic FDA data

Allergy Relief

Manufacturer
Good Sense (Geiss, Destin & Dunn, Inc.)
Effective date
2019-06-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:20:26

Label at a glance#

ProductAllergy Relief Antihistamine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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 temporarily relieves these symptoms due to the common cold: runny nose sneezing 

Dosage and administration

take every 4 to 6 hours do not take more than 6 doses in 24 hours swallow whole; do not crush, chew or dissolve adults and children 12 years of age and over  take 1 to 2 capsules  children 6 to under 12 years of age  take 1 capsule children under 6 years of age  do not use

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 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
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing 

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • swallow whole; do not crush, chew or dissolve
adults and children 12 years of age and over take 1 to 2 capsules 
children 6 to under 12 years of age take 1 capsule
children under 6 years of age do not use

Other information

OTHER SAFETY INFORMATION

  • store at 59°-77°F in a dry place. Protect from heat, humidity and light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible dye free ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

* Compare to the active ingredient in Benadryl LIQUI-GELS®

DYE-FREE

Allergy Relief

Diphenhydramine HCl 25 mg

Antihistamine

Relieves:

• Sneezing    • Runny nose  

• Itchy, watery eyes • Itchy nose or throat

SOFTGELS**

**Liquid Filled Capsules

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl®, or Catalent Pharma Solutions, Inc., owner of the registered trademark LIQUI-GELS®

PRODUCT OF CANADA

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine HCl 25 mg softgels
Diphenhydramine HCl 25 mg softgels

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-720-24EA - Each50804-720b418ce21-62bb-403a-91c5-71adacb5737f12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
GELATININACTIVE INGREDIENT2G86QN327L1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
SORBITANINACTIVE INGREDIENT6O92ICV9RU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50804-72050804-720-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 166 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GELATINGELATIN2G86QN327LINJECTION / INTRAVENOUS20 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / RESPIRATORY (INHALATION)100 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, CHEWABLE / ORAL24 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, EXTENDED RELEASE / ORAL1229 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / ORAL120 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LWAFER / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYRUP / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, FILM COATED / ORAL57 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LGUM, CHEWING / BUCCAL102 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, DELAYED RELEASE / ORAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED / ORAL288 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / SUBLINGUAL13 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / INTRAVENOUS34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, SUSPENSION / INTRAMUSCULAR1.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / NASAL50 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED PELLETS / ORAL65 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / ORAL34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / ORAL46 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR2 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYSTEM / TOPICAL1050 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTE / DENTAL252 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTILLE / ORAL143 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, EXTENDED RELEASE / ORAL239 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / SUBLINGUAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRACAVITARY0.05 mlExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / PERIODONTAL3.44 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LELIXIR / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAMUSCULAR16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / SUBCUTANEOUS16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSUPPOSITORY / VAGINALNAExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates

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
ff445bdc-57c6-40a8-bd68-547a498115a0eced5294-e6a6-446c-8789-e45e85e153cf2019-06-25WarningsExact identifier
spl id: ff445bdc-57c6-40a8-bd68-547a498115a0
spl set id: eced5294-e6a6-446c-8789-e45e85e153cf