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 |
|---|---|---|---|---|---|---|
| Childrens Mucus Cough and Congestion Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 8b5d391b-6c23-44c3-81d0-c08822bf6d01 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Night Time Multi-Symptom Cold | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | e048cd53-a3cd-484f-a972-4cb49791dba3 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cough | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | b8132c81-5291-431a-ad3a-ec8a3eb21c19 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Stuffy Nose and Chest Congestion | GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 7354f57c-0ecf-481f-9482-0040c90c4350 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 5bda415d-739f-4ca5-b5b2-07c14a81863b | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Multi-Symptom Cold and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8f3eb5c5-832e-4806-b3da-ef112cf55dcf | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE | Reckitt Benckiser LLC | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d9e5a8d7-814c-4ab1-bb05-e4cb9155978e | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack | ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | Reckitt Benckiser LLC | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 84e7be8f-2785-45ef-9c44-de05394fcd99 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 771d7fd8-184f-48a3-90ed-e8f00159d97e | 2026-05-18 | Warnings | M012 |
| MUCINEX Childrens Stuffy Nose | OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | de1c0abd-1644-4351-8106-e9df6ca5c142 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Fever Sore Throat and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 1538a75d-582a-9501-e063-6394a90a6c55 | 2026-05-18 | Warnings | M012 |
| Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 19105007-0193-0764-e063-6294a90a01a4 | 2026-05-18 | Warnings | M012 |
| Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and Flu | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 34fd2458-9acd-cdf7-e063-6394a90a3d0a | 2026-05-18 | Warnings | M012 |
| MUCINEX FAST-MAX NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3a24b06c-00a6-c2ef-e063-6294a90a4d72 | 2026-05-18 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 14be3ab0-d6ae-e342-e063-6294a90ab851 | 2026-05-18 | Warnings | M012 |
| Banophen | DIPHENHYDRAMINE HCL | Bryant Ranch Prepack | 20f00537-2c8a-45d1-8e5f-ec276d0a47b6 | 2026-05-18 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | 38df2308-f6f9-4476-ad34-4b5bc5f9fdf2 | 2026-05-18 | Warnings | M012 |
| Allergy Plus Headache Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALMART INC. | 88e3b969-79d0-4e64-95c0-c5cfd41e365f | 2026-05-18 | 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 |