FDA.reportPublic FDA data

TopCare 44-585

Manufacturer
Topco Associates, LLC | LNK International, Inc.
Effective date
2026-07-08
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
weekly-update
Hydrated at
2026-07-17 21:44:01

Label at a glance#

ProductChildrens 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 itchy, watery eyes sneezing itching of the nose or throat

Dosage and administration

find right dose on chart below chew or crush tablets completely before swallowing; do not swallow tablets whole take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours  Age (yr) Dose (chewable tablets) 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 1 to 2 chewable tablets (12.5 mg to 25 mg) adults and ch...

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid high humidity see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

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
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat

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
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

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

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages
  • marked drowsiness may occur
  • 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

  • find right dose on chart below
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
 Age (yr)Dose (chewable tablets)
children under 2 years
do not use
children 2 to 5 years   
do not use unless directed by a doctor
children 6 to 11 years1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12 years and over     
2 to 4 chewable tablets (25 mg to 50 mg)

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

+TopCare®
          health

NDC 36800-585-44

COMPARE TO CHILDREN'S
BENADRYL® CHEWABLES
ACTIVE INGREDIENT*

children's
Allergy Relief

DIPHENHYDRAMINE HCl 12.5 mg
CHEWABLE TABLETS - ANTIHISTAMINE

4-6
HOURS/
DOSE

 RELIEF OF:

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

18 CHEWABLE
     TABLETS

Chew or crush tablets completely
before swallowing.

For Ages 6 to 11 Years

GRAPE
FLAVOR

actual size

Topcare 44-585Topcare 44-585

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800414358GTIN-13: 0036800414358
EAN-13: 0036800414358
GTIN-12: 036800414358
UPC-A: 036800414358
GTIN storage (14 digits): 00036800414358		topcare-44-585-1.jpg
QR code linkQR Codetopbrnds.com/48zzritopcare-44-585-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-585-44EA - Each36800-585639102fc-5216-42f2-8788-65842f0f8fdf12024-04-05

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-58536800-585-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-07-10full-release2026-06-01 01:07:05

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 Allergy ReliefDIPHENHYDRAMINE HCLTopco Associates, LLCbfcabe02-7961-4407-a748-8cd0877313982026-07-08WarningsExact identifier
ndc (package): 36800-585-44
ndc (product): 36800-585
ndc11 (package): 36800058544
spl id: 63271716-2607-4cd3-9165-6b4dfab4c079
spl set id: bfcabe02-7961-4407-a748-8cd087731398

Reported adverse events (FAERS/openFDA)#

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