oxymetazoline hydrochloride
- Product NDC
- 68071-3422
- 11-digit product format
- 680713422
- Labeler code
- 68071
- Product ID
- 68071-3422_36b1caf3-8f0e-088c-e063-6394a90a6a07
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- oxymetazoline hydrochloride
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-12-05
- Marketing end
- 2027-02-28
- Substance
- OXYMETAZOLINE HYDROCHLORIDE
- Active strength
- .05 g/100mL
- Pharmacologic classes
- Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-3422-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-3422-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-3422-1 | 0efc9e666f02… | f202fb6c5f17… |
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
- oxymetazoline hydrochloride
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OXYMETAZOLINE HYDROCHLORIDE | .05 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| K89MJ0S5VY | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1000990 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fd058e2b-5445-e416-e053-6394a90a611b | 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-3422-1 | 2025-03-04 | C162847 | 48780-1 | 2cef2736-8f70-d83d-e063-dadaa90ab31f | Perrigo Oxymetazoline HCl 0.05% Drug Facts |
| 68071-3422-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8f70-d83d-e063-dadaa90ab31f | Perrigo Oxymetazoline HCl 0.05% Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3422-1 | oxymetazoline hydrochloride | 30 mL in 1 BOTTLE, SPRAY | SPRAY | 30 | 3 | |
| 68071-3422-1 | oxymetazoline hydrochloride | 1 in 1 CARTON | SPRAY | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3422 | OXYMETAZOLINE HYDROCHLORIDE SPRAY [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 2 package rows | 20250306_fd058e2b-5445-e416-e053-6394a90a611b.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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu Relief, 24-7 Life BY 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION | Lil' Drug Store Products, Inc. | 2771d699-3f70-4318-e063-6394a90a89cc | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Shield Pharmaceuticals Corp | 3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b | 2025-12-09 | Warnings | M012 |
| Circle K Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc | 9a32bc6d-0499-48fa-a6ad-702c8a28bf5f | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Shield Pharmaceuticals Corp | 5015a380-a229-4eff-8e31-528065c6ed64 | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | caf59320-5b48-4533-bda9-7b03a2fde0b5 | 2025-12-09 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | 30d41dc3-e2ef-4cad-b63c-d634bc749aa1 | 2025-12-09 | Warnings | M012 |
| Walgreens Childrens Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Walgreen Company | 327a7226-84b9-26d7-e063-6394a90a99b9 | 2025-12-09 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Meijer Distribution Inc | 8ed5b802-a26e-45b4-a696-bc64dbac4733 | 2025-12-09 | Warnings | M012 |
| dg health cold plus flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, LLC | ff4a2f0a-d638-4ed2-8e05-2a52afbc4909 | 2025-12-09 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 24894484-b834-4b2f-b365-c95b5e30d8bf | 2025-12-09 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Family Dollar (FAMILY WELLNESS) | 2c431220-c61b-4ad5-9ad2-58ccaee2d1c3 | 2025-12-09 | Warnings | M012 |
| Sinus PE Congestion Daytime Nighttime | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 9da77306-5098-4c79-845c-97ead849c84a | 2025-12-08 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | fdd0dadc-5313-4f6e-aef5-ca853efe5c4d | 2025-12-08 | Warnings | M012 |
| Mucolyte | GUAIFENESIN | Rising Pharma Holdings, Inc. | e4091aaf-44e3-4701-9986-aff248a2f1b8 | 2025-12-08 | Warnings | M012 |
| Mucolyte DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rising Pharma Holdings, Inc. | c913d27d-bc00-4ace-9a5f-c55522e1cd1d | 2025-12-08 | Warnings | M012 |
| honey lemon cough drops | MENTHOL | American Sales | 47f504d5-3ec5-5227-e054-00144ff88e88 | 2025-12-07 | Warnings | M012 |
| Sugar Free Menthol Cough Drops | MENTHOL | American Sales | 4893ac0a-7769-5657-e054-00144ff8d46c | 2025-12-07 | Warnings | M012 |
| Cherry cough drop | MENTHOL | American Sales | 45e891ea-2f2a-31b7-e054-00144ff88e88 | 2025-12-07 | Warnings | M012 |
| Cherry Sore Throat Lozenge | BENZOCAINE | American Sales | 49248a40-1ca3-6dd1-e054-00144ff88e88 | 2025-12-07 | Warnings | M012 |
| Sugar Free Honey Lemon Cough Drops | MENTHOL | American Sales | 4896cbd1-57dd-1fc6-e054-00144ff8d46c | 2025-12-07 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1000990 | oxymetazoline HCl 0.05 % Nasal Spray | PSN | fd058e2b-5445-e416-e053-6394a90a611b | 3 |
| 1000990 | oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray | SCD | fd058e2b-5445-e416-e053-6394a90a611b | 3 |
| 1000990 | oxymetazoline hydrochloride 0.05 % Nasal Spray | SY | fd058e2b-5445-e416-e053-6394a90a611b | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-3422-1 | 68071342201 | 1 BOTTLE, SPRAY in 1 CARTON (68071-3422-1) / 30 mL in 1 BOTTLE, SPRAY | 2023-05-31 | 2027-02-28 | No | No | Historical |