FDA.reportPublic FDA data

Dye Free Childrens Allergy Relief

Manufacturer
WAL-MART STORES INC.
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:40:48

Label at a glance#

ProductDye Free Childrens 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 Itchy of the throat or Nose

Dosage and administration

find right dose on chart below take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours mL = milliliter 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 5mL to 10 mL Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Storage and handling

each 5 mL contains: sodium 3 mg store at room temperature see bottom panel for lot number and expiration date protect from light contains low sodium

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl USP 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
    • Itchy of the throat or Nose

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

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

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

  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • mL = milliliter

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

5mL to 10 mL

Attention:use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains:sodium 3 mg
  • store at room temperature
  • see bottom panel for lot number and expiration date
  • protect from light
  • contains low sodium

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-287-1915

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to Children'sBenadryl ®Dye-Free active ingredient**

NDC 49035-600-04

Dye-Free

Children’s Allergy Relief

Diphenhydramine HCl USP 12.5 mg ǀ Antihistamine
Oral solution

For Relief of:

  • Runny Nose,
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Sugar-Free | Dye-Free

6-11 YEARS

Natural Cherry Flavor

4 FL OZ (118 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

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

IMPORTANT:Keep this carton for the future reference on full labeling.

DISTRIBUTED BY:

Walmart Inc.,

Bentonville, AR 72716

Satisfaction guaranteed- Or we’ll replace it or give you your money back. For question or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

Equate Children's Allergy Relief Cherry Flavor
Equate Children's Allergy Relief Cherry Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN7
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD7
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY7
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY7
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY7

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-600-04Dye Free Childrens Allergy Relief118 mL in 1 BOTTLE, PLASTICSOLUTION1187
49035-600-04Dye Free Childrens Allergy Relief1 in 1 CARTONSOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-600-04ML - Milliliter49035-60042cbc7ef-5fd4-4ac1-a4e2-b37d0c1fd4e312023-03-13

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-60049035-600-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM CITRATEEE90ONI6FFIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-11-15full-release2026-06-01 00:37:21

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
Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWAL-MART STORES INC.3652ee94-b762-4100-a305-5acbec5f795a2025-10-27WarningsExact identifier
ndc (package): 49035-600-04
ndc (product): 49035-600
ndc11 (package): 49035060004
spl id: 42229b75-82a1-aaf8-e063-6394a90a0b15
spl set id: 3652ee94-b762-4100-a305-5acbec5f795a

Reported adverse events (FAERS/openFDA)#

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