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NDC 63868-0605-01 OXYMETAZOLINE HYDROCHLORIDE 0.05 g/100mL Details
OXYMETAZOLINE HYDROCHLORIDE 0.05 g/100mL
OXYMETAZOLINE HYDROCHLORIDE is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by CHAIN DRUG MARKETING ASSOCIATION INC.. The primary component is OXYMETAZOLINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymetazoline nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should use oxymetazoline nasal spray carefully and under adult supervision. Oxymetazoline is in a class of medications called nasal decongestants. It works by narrowing the blood vessels in the nasal passages.
Related Packages: 63868-0605-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Oxymetazoline Nasal Spray
Product Information
| NDC | 63868-0605 |
|---|---|
| Product ID | 63868-605_7abfe9c8-a55e-4b62-84a3-fa5f14aae007 |
| Associated GPIs | |
| GCN Sequence Number | 008037 |
| GCN Sequence Number Description | oxymetazoline HCl MIST 0.05 % NASAL |
| HIC3 | Q7D |
| HIC3 Description | NOSE PREPARATIONS, VASOCONSTRICTORS(OTC) |
| GCN | 34050 |
| HICL Sequence Number | 003417 |
| HICL Sequence Number Description | OXYMETAZOLINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | OXYMETAZOLINE HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | OXYMETAZOLINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SPRAY |
| Route | NASAL |
| Active Ingredient Strength | 0.05 |
| Active Ingredient Units | g/100mL |
| Substance Name | OXYMETAZOLINE HYDROCHLORIDE |
| Labeler Name | CHAIN DRUG MARKETING ASSOCIATION INC. |
| Pharmaceutical Class | Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63868-0605-01 (63868060501)
| NDC Package Code | 63868-605-01 |
|---|---|
| Billing NDC | 63868060501 |
| Package | 30 mL in 1 BOTTLE, SPRAY (63868-605-01) |
| Marketing Start Date | 2021-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c7b1f980-9b0d-4f63-a70d-fd366658f863 Details
Uses
Warnings
Ask a doctor before use if you have
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
When using this product
- do not use more than directed
- do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
- temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
- use of this container by more than one person may spread infection
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
- adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10-12 hours. Do not exceed 2 doses in any 24-hour period.
- children under 6 years of age: ask a doctor
- Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides and tum in a counter-clockwise direction and pull off to remove. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tiltlng the head insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap back onto the bottle.
Other information
Inactive ingredients
- No Drip Original Nasal Pump Mist- (NDC-63868-605-01) avicel. benzalkonium chloride, benzyl alcohol. dibasic sodium phosphate, edetate disodium dihydrate, flavor, monobasic sodium phosphate, polyethylene glycol, povidone, purified water
- No Drip Extra Moisturizing Nasal Pump Mist- (NDC-63868-676-01) avicel. benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium dihydrate, glycerin, monobasic sodium phosphate, polyethylene glycol, povidone, purified water
SPL UNCLASSIFIED SECTION
- Tamper Evident: Do not use the product if the temper evident seal is broken or missing.
- This product is not manufactured or distributed by Bayer HealthCare LLC distributor of Afrin Original Nasal Spray.
Questions or comments?1-800-935-2362, Mon-Fri. 9 am-5 pm EST)
Distributed by C.D.M.A Inc.
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Question: 800-935-2362
INGREDIENTS AND APPEARANCE
| OXYMETAZOLINE HYDROCHLORIDE
oxymetazoline hydrochloride spray |
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| OXYMETAZOLINE HYDROCHLORIDE
oxymetazoline hydrochloride spray |
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| Labeler - CHAIN DRUG MARKETING ASSOCIATION INC. (011920774) |
| Registrant - Seaway Pharma Inc. (117218785) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Seaway Pharma Inc. | 117218785 | manufacture(63868-605, 63868-676) | |
Revised: 8/2021
Document Id: 7abfe9c8-a55e-4b62-84a3-fa5f14aae007
Set id: c7b1f980-9b0d-4f63-a70d-fd366658f863
Version: 1
Effective Time: 20210803