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 |
|---|---|---|---|---|---|---|
| Halls Sugar Free Honey Lemon | MENTHOL | Mondelez Global LLC | 5d56ccd2-1c28-4750-9454-44809091ad2f | 2025-02-05 | Warnings | M012 |
| SanaTos Mucus Relief Cold Toddlers | DEXTROMETHORPHAN HBR, GUAIFENESIN | Pharmadel LLC | 60672feb-1421-651e-e053-2a91aa0af41d | 2025-02-04 | Warnings | M012 |
| SofSkin Vaporizing Chest Rub and Cough Suppressant | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Viny Health and Beauty Inc | 34626cf5-64fc-15c0-e063-6294a90aa310 | 2025-02-04 | Warnings | M012 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS PHARMACY, INC | 17922df7-7867-4300-bd99-55aee7b60606 | 2025-02-04 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | f4b8ff54-47b5-4d18-bf4e-b101abb22a24 | 2025-02-03 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | f40bfdfc-1cb4-4604-9790-fb8d1d5173c6 | 2025-01-31 | Warnings | M012 |
| NIGHTIME COLD AND FLU | NIGHTIME COLD AND FLU | TARGET CORP | 9dee9b92-eac9-b07d-e053-2995a90a0602 | 2025-01-31 | Warnings | M012 |
| Rugby Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Bryant Ranch Prepack | 7b23faa9-40c8-4cea-b9fb-487cce2664af | 2025-01-31 | Warnings | M012 |
| BENADRYL Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 224ba2a3-1a93-29c8-e063-6394a90a9bef | 2025-01-30 | Warnings | M012 |
| Extra Strength Nite-Time Pain Relief | 430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLET | WALGREENS | c25cff5a-93f5-62aa-e053-2a95a90aa7b4 | 2025-01-30 | Warnings | M012 |
| NIGHTTIME COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WALGREENS | dbf5c814-4e69-13ac-e053-2a95a90a49a3 | 2025-01-30 | Warnings | M012 |
| Mucus DM Fast Max Day Cold and Flu and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | WALGREENS | f3770976-de73-52b8-e053-2995a90aad4f | 2025-01-30 | Warnings | M012 |
| Dextromethorphan HBr and Guaifenesin Oral Solution | DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION | KESIN PHARMA CORPORATION | 284eae44-81bc-400c-e063-6394a90af446 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26c82bc3-5753-4d56-96a4-a3f9c8c267d0 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 8095b211-8ae7-44e5-b89a-b7f730e28d51 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2cf2f35b-5d59-e3ff-e063-6294a90a9b45 | 2025-01-30 | Warnings | M012 |
| Sinus Congestion and Pain Relief Non-Drowsy, Daytime | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5 | 2025-01-30 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cold and Flu | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | RB Health (US) LLC | 2ce20ab5-5f2d-1c97-e063-6394a90ad67b | 2025-01-29 | Warnings | M012 |
| Guaifenesin and Dextromethorphan | GUAIFENESIN AND DEXTROMETHORPHAN | Major Pharmaceuticals | 97b137c9-0bec-409a-91f7-e298c296578b | 2025-01-29 | Warnings | M012 |
| Childrens Mucus and Cough Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS | 1dc17665-62ce-f7f5-e063-6294a90af851 | 2025-01-29 | 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 |