NDC 0641-1495-31 - Promethazine Hydrochloride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0641-1495
- Requested NDC
- 0641-1495-31
- Package NDCs from labels
- 0641-1495-31, 0641-1495-35
- Manufacturer
- Henry Schein, Inc.
- Effective date
- 2025-11-07
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Promethazine HCL 25 mg/mL Injection, USP 1 mL Single Dose Ampule | Henry Schein, Inc. | 2025-11-07 | HUMAN PRESCRIPTION DRUG LABEL |
| Promethazine Hydrochloride Injection, USP | Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A | 2025-06-30 | HUMAN PRESCRIPTION DRUG LABEL |
| Promethazine Hydrochloride Injection, USP | REMEDYREPACK INC. | 2023-10-03 | HUMAN PRESCRIPTION DRUG LABEL |
| Promethazine Hydrochloride - Medical Purchasing Solutions, LLC | Medical Purchasing Solutions, LLC | 2023-05-02 | HUMAN PRESCRIPTION DRUG LABEL |
| Promethazine Hydrochloride - General Injectables & Vaccines, Inc | General Injectables & Vaccines, Inc | 2022-12-29 | HUMAN PRESCRIPTION DRUG LABEL |
| Model AA-8565CV-ACT Model AA-8565CV - Aerospace Accessory Service, Inc | Aerospace Accessory Service, Inc | 2021-05-18 | MEDICAL DEVICE |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
| Promethazine Hydrochloride Injection, USP Rx only | Dispensing Solutions Inc. | 2010-03-02 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-1495-31 | Promethazine Hydrochloride | 1 mL in 1 AMPULE | INJECTION | 1 | 5 | |
| 0641-1495-35 | Promethazine Hydrochloride | 25 in 1 CARTON | INJECTION | 25 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-1495-31 | ML - Milliliter | 0641-1495 | 8f71d813-efd2-4f08-b2fa-1b5da840c091 | 1 | 2012-07-24 |
| 0641-1495-35 | ML - Milliliter | 0641-1495 | 4630f281-0707-4994-872a-ee7bd8a6722d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| COLTALIN-DM | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | FORTUNE PHARMACAL COMPANY LIMITED | 33e1bec0-323b-40b7-809a-cb65a71ad0ce | 2026-09-17 | Warnings | 362O9ITL9D |
| Lymph Tonic II | ECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANA | BioActive Nutritional, Inc. | 0e3265b0-b210-4a4c-80d2-8a9712981d4e | 2026-09-17 | Warnings | ETJ7Z6XBU4 451W47IQ8X |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | REMEDYREPACK INC. | 0ca72c89-82c5-4b31-b515-1a8b8e82ec59 | 2026-09-10 | Warnings, Adverse reactions | 866511 W5S57Y3A5L |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | Kroger Company | fd41e4a4-330f-4409-8ba3-0b3bb6f45bca | 2026-09-10 | Warnings | 362O9ITL9D |
| Nighttime Sleep Aid Berry Flavor | DIPHENHYDRAMINE HYDROCHLORIDE | Raritan Pharmaceuticals Inc | 303d7651-9c8f-4a14-9f2c-7181fa0f003e | 2026-09-09 | Warnings | TC2D6JAD40 |
| childrens fever reducer and pain reliever | ACETAMINOPHEN | Rite Aid Corporation | 7f445de3-30cf-4bd8-892d-05979cd399e7 | 2026-09-09 | Warnings | 362O9ITL9D |
| dual action | ACETAMINOPHEN, IBUPROFEN | Rite Aid Corporation | 54b08d24-d5e9-4111-9d97-329896e8309d | 2026-09-09 | Warnings | 362O9ITL9D |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Raritan Pharmaceuticals Inc | 2cb3e17f-3858-4773-a53f-0860ae6ff1b9 | 2026-09-09 | Warnings | 362O9ITL9D |
| calcium chloride | CALCIUM CHLORIDE | Eskayef Pharmaceuticals Limited | 5b0bd762-4c87-597e-e063-6394a90a8303 | 2026-09-09 | Warnings, Adverse reactions | M4I0D6VV5M |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | W Aesthetics | 5b0f2c8f-d6fa-5e25-e063-6394a90a084d | 2026-09-09 | Warnings | 15FIX9V2JP |
| Advanced Alcohol Gel Sanitizer | ALCOHOL | Betco Corporation, Ltd | a23b997c-b010-5985-e053-2995a90aadf3 | 2026-09-09 | Warnings | 3K9958V90M |
| North Woods Derma Foam Hand Sanitizer | BENZALKONIUM CHLORIDE | Superior Chemical Corporation | ad51a175-2b91-fd14-e053-2995a90ad54d | 2026-09-09 | Warnings | F5UM2KM3W7 |
| Touchland Power Mist Hydrating Hand Sanitizer Cotton Candy | ALCOHOL | Church & Dwight Co., Inc. | 5b107dd2-a76c-9c80-e063-6394a90aaedb | 2026-09-09 | Warnings | 3K9958V90M |
| Pink Touchland Power Mist Hydrating Hand Sanitizer Wild Watermelon | ALCOHOL | Church & Dwight Co., Inc. | 5b108f13-6474-fdbd-e063-6294a90a1a2b | 2026-09-09 | Warnings | 3K9958V90M |
| Touchland Power Mist Hydrating Hand Sanitizer Mango Passion | ALCOHOL | Church & Dwight Co., Inc. | 5b1099ae-f1e8-b79d-e063-6394a90add6f | 2026-09-09 | Warnings | 3K9958V90M |
| Touchland Gentle Mist Hand Sanitizer Lily of The Valley | ALCOHOL | Church & Dwight Co., Inc. | 5b10a3a7-1cca-2a34-e063-6294a90a3f6c | 2026-09-09 | Warnings | 3K9958V90M |
| Alcohol Free Foaming Hand Sanitizer | BENZALKONIUM CHLORIDE | Betco Corporation, Ltd. | 7e038b0a-4813-4f4b-ad66-0584d75a064f | 2026-09-09 | Warnings | F5UM2KM3W7 |
| Burn Cream | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | Trifecta Pharmaceuticals USA LLC | e9a9fc7c-31da-ea3f-e053-2a95a90a0eab | 2026-09-09 | Warnings | M003 F5UM2KM3W7 |
| Ultra Blue Antibacterial Foaming Skin Cleanser | BENZALKONIUM CHLORIDE | Betco Corporation, Ltd | aa8f5b05-882d-d05a-e053-2995a90abaea | 2026-09-09 | Warnings | F5UM2KM3W7 |
| Touchland Glow Mist Hand Sanitizer Rosewater | ALCOHOL | Church & Dwight Co., Inc. | 5a850866-bc5d-e595-e063-6394a90a335f | 2026-09-09 | Warnings | 3K9958V90M |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.