Vicks Sinex Severe
- Product NDC
- 64336-170
- 11-digit product format
- 643360170
- Labeler code
- 64336
- Product ID
- 64336-170_500f54a4-3615-924d-e063-6294a90af20f
- 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
- 2018-12-20
- 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
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 |
|---|---|
| cfd048c9-2f33-101d-e053-2995a90ad854 | 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 |
|---|---|---|---|---|---|---|
| 64336-170-01 | Vicks Sinex SevereOriginal | 15 mL in 1 BOTTLE, SPRAY | SPRAY | 15 | 8 | |
| 64336-170-01 | Vicks Sinex SevereOriginal | 1 in 1 CARTON | SPRAY | 1 | 8 |
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 |
|---|---|---|---|---|---|---|
| Foster and Thrive Adult Tussin DM MAX | DEXTROMETHORPHAN HBR, GUAIFENESIN | Strategic Sourcing Services LLC | 5f6e4d56-4a66-4dbd-97c8-550310dea358 | 2024-11-05 | Warnings | M012 |
| Cough Drops Honey Lemon with Sugar | MENTHOL | Lidl US LLC | 4ad9398f-7488-6eaf-e054-00144ff8d46c | 2024-11-05 | Warnings | M012 |
| rexall dm cough and congestion relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dolgencorp, LLC | 906838b1-a742-4728-944d-42b687b8cd59 | 2024-11-05 | Warnings | M012 |
| tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | H E B | 7c24c59c-7549-4c64-95f8-4bf755cd6f61 | 2024-11-05 | Warnings | M012 |
| equate adult tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Wal-Mart Stores Inc | 3592e000-a6c6-47fe-8bb0-9341c65c2959 | 2024-11-05 | Warnings | M012 |
| tussin dm max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Walgreen Company | 756794b0-8d3b-4732-947c-a407caf400e2 | 2024-11-05 | Warnings | M012 |
| basic care tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Amazon.com Services LLC | c6863e31-e1b9-40ff-ae2e-4aec86b4acc0 | 2024-11-05 | Warnings | M012 |
| topcare tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Topco Associates LLC | 94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a | 2024-11-05 | Warnings | M012 |
| Childrens Sudafed PE NASAL DECONGESTANT | PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d | 2024-11-04 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | 164b2559-2d3f-431e-a03c-07e86731af5c | 2024-11-04 | Warnings | M012 |
| tussin severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | 7cc2c136-d1b7-4658-99bb-73bb1d140261 | 2024-11-04 | Warnings | M012 |
| dg health tussin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | a5d0ee70-d528-4a53-bf01-7bb13b364ed0 | 2024-11-04 | Warnings | M012 |
| basic care tussin cf severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | bba9a17d-eb87-46f3-acee-c9dd34e5bfd4 | 2024-11-04 | Warnings | M012 |
| topcare tussin cf max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | b553b7e6-933b-49e3-97d3-22a4643a04b9 | 2024-11-04 | Warnings | M012 |
| dg health nasal original | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | fb209752-705a-4bb0-9298-8b70357f3911 | 2024-11-02 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | H E B | 3c301993-642a-487c-96a2-ebc4ef90dc88 | 2024-11-02 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 1341744c-43c3-462b-b93c-1e46476fd935 | 2024-11-01 | Warnings | M012 |
| Nighttime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | 43784616-1afd-4ff7-8fee-6ac389f616a2 | 2024-11-01 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates LLC | 28ef87e8-29e5-444d-b1f7-5c38a7f758d3 | 2024-11-01 | Warnings | M012 |
| Good Sense Severe NightTime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | L. Perrigo Company | 0e3c36c9-d45b-41b9-891d-a42d854295f9 | 2024-11-01 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1000990 | oxymetazoline HCl 0.05 % Nasal Spray | PSN | cfd048c9-2f33-101d-e053-2995a90ad854 | 8 |
| 1001066 | Vicks Sinex 12Hr Decongestant 0.05 % Nasal Spray | PSN | cfd048c9-2f33-101d-e053-2995a90ad854 | 8 |
| 1001066 | oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting] | SBD | cfd048c9-2f33-101d-e053-2995a90ad854 | 8 |
| 1000990 | oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray | SCD | cfd048c9-2f33-101d-e053-2995a90ad854 | 8 |
| 1000990 | oxymetazoline hydrochloride 0.05 % Nasal Spray | SY | cfd048c9-2f33-101d-e053-2995a90ad854 | 8 |
| 1001066 | Sinex Long-Acting 0.5 MG/ML Nasal Spray | SY | cfd048c9-2f33-101d-e053-2995a90ad854 | 8 |
| 1001066 | Vicks Sinex 12-HR Decongestant 0.05 % Nasal Spray | SY | cfd048c9-2f33-101d-e053-2995a90ad854 | 8 |
| 1001066 | Vicks Sinex 12-HR Ultra Fine Moisturizing 0.05 % Nasal Spray | SY | cfd048c9-2f33-101d-e053-2995a90ad854 | 8 |
| 1001066 | Vicks Sinex Long-Acting 0.05 % Nasal Spray | SY | cfd048c9-2f33-101d-e053-2995a90ad854 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64336-170-01 | 64336017001 | 1 BOTTLE, SPRAY in 1 CARTON (64336-170-01) / 15 mL in 1 BOTTLE, SPRAY | 2018-12-20 | 2028-02-28 | No | No | Current |