Nasal Four
- Product NDC
- 42507-648
- 11-digit product format
- 425070648
- Labeler code
- 42507
- Product ID
- 42507-648_153b92b2-ab87-4249-b782-f0407c65664e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Phenylephrine hydrochloride
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- HyVee Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2003-05-03
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 1 g/100mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 42507-648-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 42507-648-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 42507-648-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 42507-648-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 42507-648-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 42507-648-10 | cdf11ea48f46… | ba0047e9e063… |
| 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 | 42507-648-10 | 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 | 42507-648-10 | 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 | 42507-648-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 42507-648-10 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 42507-648-10 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 42507-648-10 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Nasal Four
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 1 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1087043 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 19879fc8-4962-4c6e-87ed-b874d1d564af | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42507-648-10 | Nasal Four | 30 mL in 1 BOTTLE | SPRAY | 30 | 4 | |
| 42507-648-10 | Nasal Four | 1 in 1 CARTON | SPRAY | 1 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [HYVEE INC] | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [HYVEE INC] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [HYVEE INC] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [HYVEE INC] | 1 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [HYVEE INC] | 1 | |
| SODIUM BORATE | INACTIVE INGREDIENT | 91MBZ8H3QO | NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [HYVEE INC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [HYVEE INC] | 1 |
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 |
|---|---|---|---|---|---|---|
| MUCOSA | GUAIFENESIN | TIME CAP LABORATORIES,INC | d34ef2e8-adc2-48e5-a572-e354937daec6 | 2023-11-02 | Warnings | M012 |
| Daytime Severe and Nighttime Severe cold and flu | DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 09286d15-b63f-a9de-e063-6294a90ab948 | 2023-11-02 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | AMERIFOODS TRADING COMPANY | f6cece6c-23e4-7811-e053-6394a90a106a | 2023-11-02 | Warnings | M012 |
| Sinus Pressure plus Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | eb64750f-19ac-655f-e053-2995a90a33b5 | 2023-11-02 | Warnings | M012 |
| Multi-Symptom Mapap Cold Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Proficient Rx LP | 9bf81b26-38b4-486c-ae89-222119ce1a4f | 2023-11-01 | Warnings | M012 |
| Guaifenesin Syrup and Dextromethorphan | GUAIFENESIN SYRUP AND DEXTROMETHORPHAN | Natco Pharma USA LLC | ad9026f4-f0b6-4d02-aa44-f0460eeefc0e | 2023-11-01 | Warnings | M012 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HYDROCHLORIDE | Natco Pharma USA LLC | 54b64354-ac10-42ff-a53d-96cef933a91a | 2023-11-01 | Warnings | M012 |
| children allergy relief dye free cherry | DIPHENHYDRAMINE HCL | A-S Medication Solutions | 5c6c1809-4c6f-4e8f-a5ae-9796e821d400 | 2023-11-01 | Warnings | M012 |
| Daytime and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0903b222-1a44-64aa-e063-6294a90abba0 | 2023-10-31 | Warnings | M012 |
| Ephrine Nose Drops | PHENYLEPHRINE HYDROCHLORIDE | Walgreens | b620eb9f-2caf-0942-e053-2a95a90ae48e | 2023-10-31 | Warnings | M012 |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | A-S Medication Solutions | 204849d1-ac4b-4dbe-8769-fcb30291f880 | 2023-10-31 | Warnings | M012 |
| Daytime Cold and Flu Relief | DAYTIME COLD AND FLU RELIEF | TopCo Associates, LLC | d592fbb8-d4bf-444e-982e-edf6fe97dce4 | 2023-10-31 | Warnings | M012 |
| Nite Time Cold and Flu Relief | NITE TIME COLD AND FLU RELIEF | TopCo Associates, LLC | 407dc4ae-882d-4a49-8884-ef048bb404cf | 2023-10-31 | Warnings | M012 |
| 12 Hour Original Nasal Decongestant | NASAL SPRAY | Sheffield Pharmaceuticals LLC | cea0ce76-ae75-4484-a7c2-ff1086e9d8b0 | 2023-10-30 | Warnings | M012 |
| Mucosa DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Magno-Humphries, Inc. | 3a5533fb-1c83-4b95-9cd2-9be663d3ff5f | 2023-10-27 | Warnings | M012 |
| Mucosa Guifenesin | GUAIFENESIN | Magno-Humphries, Inc. | 9d22c208-d0ae-8b6a-e053-2995a90ab90a | 2023-10-27 | Warnings | M012 |
| DG Health Cough Drops Cherry Flavor | MENTHOL | Dollar General Corporation | c7a603d8-72fb-9626-e053-2995a90a09ea | 2023-10-26 | Warnings | M012 |
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | Geri-Care Pharmaceutical Corp | 92d90b41-0627-121e-e053-2995a90a2df1 | 2023-10-26 | Warnings | M012 |
| Freegells Cough Drops Menthol Cherry | MENTHOL | Riclan S.A. | 8e471265-3594-451a-8921-f0db474abe85 | 2023-10-26 | Warnings | M012 |
| Freegells Cough Drops Menthol Eucalyptus | MENTHOL | Riclan S.A. | 1141593a-f3ba-4adf-b332-f9fcb0b5a013 | 2023-10-26 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1087043 | phenylephrine HCl 1 % Nasal Spray | PSN | 19879fc8-4962-4c6e-87ed-b874d1d564af | 4 |
| 1087043 | phenylephrine hydrochloride 10 MG/ML Nasal Spray | SCD | 19879fc8-4962-4c6e-87ed-b874d1d564af | 4 |
| 1087043 | phenylephrine hydrochloride 1 % Nasal Spray | SY | 19879fc8-4962-4c6e-87ed-b874d1d564af | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42507-648-10 | 42507064810 | 1 BOTTLE in 1 CARTON (42507-648-10) / 30 mL in 1 BOTTLE | 1 bottle | 2003-05-03 | No | No | Current |