Oxymethazoline HCL
- Product NDC
- 71205-383
- 11-digit product format
- 712050383
- Labeler code
- 71205
- Product ID
- 71205-383_9cea7bfa-fe61-4071-a168-35e122bbe4d9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Oxymethazoline HCL
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Proficient Rx LP
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-01-01
- Substance
- OXYMETAZOLINE HYDROCHLORIDE
- Active strength
- .05 mg/1
- Pharmacologic classes
- Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxymethazoline HCL
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OXYMETAZOLINE HYDROCHLORIDE | .05 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| K89MJ0S5VY | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 96883e5f-18b5-4c1c-b984-756cb86be6ff | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| e67be450-f8e4-4bc1-88bd-1259d379f55f | Product name | 1 | 20210127 |
| c53f3286-4062-4cf5-8355-399519c639a6 | Product name | 1 | 20170424 |
| a993dfc5-f219-4460-bde6-30dd724d9ef0 | Product name | 1 | 20160818 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71205-383-30 | Oxymethazoline HCL | 1 in 1 CARTON | SPRAY | 1 | 4 | |
| 71205-383-30 | Oxymethazoline HCL | 1 in 1 BOTTLE, SPRAY | SPRAY | 1 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71205-383-30 | ML - Milliliter | 71205-383 | 511c1713-fb84-4858-aba3-75f6d5d3f3b7 | 1 | 2020-03-10 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Cold and Cough | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 75862805-2cfe-fb45-e053-2991aa0a1403 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5172dc01-4e7f-3307-e054-00144ff8d46c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 20ae92d9-fbc6-5b7a-e063-6294a90a15c3 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51c44970-06e5-082e-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 54236151-37db-0b5a-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 52542774-fd05-640c-e054-00144ff8d46c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51dca689-e4a0-5526-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 6f2d18f6-935f-9215-e053-2a91aa0aedd3 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTRMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 6fb28fa1-ebbb-64bf-e053-2991aa0a1de4 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5213ca7f-5a78-6471-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 6f7ba256-ed14-5fe0-e053-2a91aa0aacc1 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 6f7bf92d-4aaf-86e0-e053-2991aa0a2d91 | 2025-12-04 | Warnings | M012 |
| Afrin NoDrip Allergy Sinus Night | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | b023a571-7e54-7c63-e053-2a95a90a0f78 | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Cough and Cold | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE | Bayer HealthCare LLC. | b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d | 2025-12-04 | Warnings | M012 |
| Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | e3231869-8ddf-9d17-e053-2995a90ae6d5 | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Multi Symptom Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | ae7cf41e-b618-d6bb-e053-2a95a90a6692 | 2025-12-04 | Warnings | M012 |
| Afrin Allergy Sinus Nasal | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | c2d903bf-5c51-82d7-e053-2995a90aea49 | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Cold, Cough and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 351d3c5c-05c8-921a-e063-6394a90abef9 | 2025-12-04 | Warnings | M012 |
| Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | e3b239bd-ffc7-600c-e053-2a95a90a3b3b | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Cold Flu And Chest Congestion | ACETAMINOPHEN, GUAIFENESIN | Bayer HealthCare LLC. | de95d2dd-e766-f7ec-e053-2995a90afc5f | 2025-12-04 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71205-383-30 | 71205038330 | 1 BOTTLE, SPRAY in 1 CARTON (71205-383-30) / 1 SPRAY in 1 BOTTLE, SPRAY | 2019-01-10 | 0000-00-00 | No | No | Current |