FDA.reportPublic FDA data

Rite Aid 44-018

Manufacturer
Rite Aid Corporation | LNK International, Inc.
Effective date
2026-05-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-06-04 05:10:15

Label at a glance#

ProductChildrens Dye Free Allergy Relief
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

Dosage and administration

do not take more than directed find right dose on chart below mL = milliliter only use the dose cup provided  take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours  Age (yr) Dose (mL) children under 2 years  do not use  children 2 to 5 years do not use unless directed by a doctor  children 6 to 11 years  5 mL to 10 mL

Storage and handling

each 5 mL contains: sodium 4 mg store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 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 the child has

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

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

  • do not take more than directed
  • find right dose on chart below
  • mL = milliliter
  • only use the dose cup provided 
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
 Age (yr)Dose (mL)
children under 2 years do not use 
children 2 to 5 years

do not use unless
directed by a doctor 

children 6 to 11 years 5 mL to 10 mL

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 4 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FREE
FROM
SUGAR FREE
ALCOHOL FREE

Compare to the
active ingredient in
Children’s Benadryl®
Dye-Free Allergy*

NDC 11822-0918-1

AGES 6-11

CHILDREN’S
DYE-FREE
ALLERGY RELIEF

DIPHENHYDRAMINE
HCl 12.5 mg / 5 mL
Oral Solution
ANTIHISTAMINE

for relief of:
sneezing,
runny nose,
itchy throat or nose,
itchy, watery eyes

CLEAR BUBBLE
GUM FLAVOR

DOSAGE CUP INCLUDED

4 FL OZ (118 mL)

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Children’s Benadryl® Dye-Free Allergy.

50844              ORG012301836

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

OUR PROMISE
Dye Free

DOSAGE CUP INCLUDED

DISTRIBUTED BY:
RITE AID
200 NEWBERRY COMMONS
ETTERS, PA 17319
www.riteaid.com

SATISFACTION
GUARANTEE
If you’re not satisfied, we’ll
happily refund your money.

Rite Aid 44-018Rite Aid 44-018

 

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-130011822231053GTIN-13: 0011822231053
EAN-13: 0011822231053
GTIN-12: 011822231053
UPC-A: 011822231053
GTIN storage (14 digits): 00011822231053		rite-aid-44-018-1.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

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-091811822-0918-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-05-10full-release2026-06-01 01:00:47

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
Childrens Dye Free Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporation74ff4f0d-7952-4b74-b1b2-5a2beab91f7c2026-05-22WarningsExact identifier
ndc (package): 11822-0918-1
ndc (product): 11822-0918
ndc11 (package): 11822091801
spl id: 8289f2aa-2ef5-429a-ad7d-8a537d2f528f
spl set id: 74ff4f0d-7952-4b74-b1b2-5a2beab91f7c

Reported adverse events (FAERS/openFDA)#

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