Vicks Sinex SEVERE
- Product NDC
- 64336-171
- 11-digit product format
- 643360171
- Labeler code
- 64336
- Product ID
- 64336-171_500f4e9a-1229-dc5d-e063-6294a90afe5c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Oxymetazoline Hydrochloride
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Procter & Gamble Manufacturing GmbH,
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-04-27
- Marketing end
- 2028-02-28
- Substance
- OXYMETAZOLINE HYDROCHLORIDE
- Active strength
- .0005095 g/mL
- Pharmacologic classes
- Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
- NDC exclude flag
- No
- 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
- Vicks Sinex SEVERE
- Brand name suffix
- ORIGINAL ULTRA FINE MIST
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OXYMETAZOLINE HYDROCHLORIDE | .0005095 g/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| K89MJ0S5VY | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cfd43b8f-8064-6b88-e053-2a95a90a329e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64336-171-01 | Vicks Sinex SEVEREORIGINAL ULTRA FINE MIST | 15 mL in 1 BOTTLE, PUMP | SPRAY | 15 | 9 | |
| 64336-171-01 | Vicks Sinex SEVEREORIGINAL ULTRA FINE MIST | 1 in 1 CARTON | SPRAY | 1 | 9 | |
| 64336-171-02 | Vicks Sinex SEVEREORIGINAL ULTRA FINE MIST | 15 mL in 1 BOTTLE, PUMP | SPRAY | 15 | 9 | |
| 64336-171-02 | Vicks Sinex SEVEREORIGINAL ULTRA FINE MIST | 2 in 1 CARTON | SPRAY | 2 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64336-171 | VICKS SINEX 12 HOUR DECONGESTANT ULTRA FINE MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PROCTER & GAMBLE MANUFACTURING GMBH,] | 6 | Current NDC, Legacy NDC, 4 package rows | 20241012_cfd43b8f-8064-6b88-e053-2a95a90a329e.zip |
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 |
|---|---|---|---|---|---|---|
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0 | 2025-08-18 | Warnings | M012 |
| MAJOR NASAL DECONGESTANT | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | 4b78b9af-0975-43f8-8b44-daddef0478be | 2025-08-15 | Warnings | M012 |
| Dr Simi Mucus Relief Expectorant | GUAIFENESIN | Farmacias De Similares TX LLC | 3c6d0e75-a685-6020-e063-6294a90a5c1b | 2025-08-15 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 25bf4390-23f7-4bb6-b86e-c40eaf8d92da | 2025-08-15 | Warnings | M012 |
| Childrens Chewable Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2cac72be-4830-ad49-e063-6394a90a7832 | 2025-08-14 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTH | DEXTROMETHORPHAN HBR AND GUAIFENESIN | AMERISOURCE BERGEN | 2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e | 2025-08-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walmart Inc. | 16fae164-28db-8ef1-e063-6294a90ab5da | 2025-08-12 | Warnings | M012 |
| Exchange Select Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | fbece335-a7e5-4732-a086-561b23741579 | 2025-08-12 | Warnings | M012 |
| MGC Health Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 779ddb89-b6e2-4bfb-bcb5-8c7ec916675a | 2025-08-12 | Warnings | M012 |
| Equaline Nasal | OXYMETAZOLINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | d7fa1720-eac4-4e82-9401-77215ce4f545 | 2025-08-12 | Warnings | M012 |
| Diabetic Tussin DM Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | MEDTECH PRODUCTS INC | a10a3b33-7503-4334-8ed7-2bb881df4327 | 2025-08-08 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health, Inc | 26a55d74-f772-5d17-e063-6394a90a5583 | 2025-08-07 | Warnings | M012 |
| Daytime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | b7434978-44a8-4c51-979d-0bc446461e43 | 2025-08-06 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | fc1e224c-5c57-43fc-ae6e-36aa0a4ae439 | 2025-08-06 | Warnings | M012 |
| childrens cold cough dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Publix Super Markets Inc | 6efe7097-2a99-4654-9d94-b47f2e64d19d | 2025-08-05 | Warnings | M012 |
| Quality Choice Throat Soothing Drops Creamy Strawberry | PECTIN | Chain Drug Marketing Association, Inc. | 3b7548ee-7cd3-62c3-e063-6294a90a0612 | 2025-08-03 | Warnings | M012 |
| Vaporizing chest rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | LJ Pharma | 065bb666-e482-4e96-ac75-c6577dcc5b48 | 2025-08-01 | Warnings | M012 |
| Nighttime Cough-Kids | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Genexa | 024bb864-4214-1d8b-e063-6394a90aa573 | 2025-08-01 | Warnings | M012 |
| Antigrip Cough and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Pharmadel LLC | 3b53e5fc-f258-c2b9-e063-6394a90ab500 | 2025-08-01 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2025-08-01 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1000990 | oxymetazoline HCl 0.05 % Nasal Spray | PSN | cfd43b8f-8064-6b88-e053-2a95a90a329e | 9 |
| 1001066 | Vicks Sinex 12Hr Decongestant 0.05 % Nasal Spray | PSN | cfd43b8f-8064-6b88-e053-2a95a90a329e | 9 |
| 1001066 | oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting] | SBD | cfd43b8f-8064-6b88-e053-2a95a90a329e | 9 |
| 1000990 | oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray | SCD | cfd43b8f-8064-6b88-e053-2a95a90a329e | 9 |
| 1000990 | oxymetazoline hydrochloride 0.05 % Nasal Spray | SY | cfd43b8f-8064-6b88-e053-2a95a90a329e | 9 |
| 1001066 | Sinex Long-Acting 0.5 MG/ML Nasal Spray | SY | cfd43b8f-8064-6b88-e053-2a95a90a329e | 9 |
| 1001066 | Vicks Sinex 12-HR Decongestant 0.05 % Nasal Spray | SY | cfd43b8f-8064-6b88-e053-2a95a90a329e | 9 |
| 1001066 | Vicks Sinex 12-HR Ultra Fine Moisturizing 0.05 % Nasal Spray | SY | cfd43b8f-8064-6b88-e053-2a95a90a329e | 9 |
| 1001066 | Vicks Sinex Long-Acting 0.05 % Nasal Spray | SY | cfd43b8f-8064-6b88-e053-2a95a90a329e | 9 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64336-171-01 | 64336017101 | 1 BOTTLE, PUMP in 1 CARTON (64336-171-01) / 15 mL in 1 BOTTLE, PUMP | 2015-04-27 | 2028-02-28 | No | No | Current |
| 64336-171-02 | 64336017102 | 2 BOTTLE, PUMP in 1 CARTON (64336-171-02) / 15 mL in 1 BOTTLE, PUMP | 2015-04-27 | 2028-02-28 | No | No | Current |