Over-the-counter drug · OTC MONOGRAPH DRUG
Nighttime Sleep-Aid Non-Habit Forming NDC 76281-522
diphenhydramine hci · Diphenhydramine hydrochloride 50 mg/30mL · Liquid · Oral · AptaPharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76281-522-24 | 76281052224 | 118 mL in 1 BOTTLE (76281-522-24)Marketed from Jan 1, 2018 | |
| 76281-522-25 | 76281052225 | 177 mL in 1 BOTTLE (76281-522-25)Marketed from Jan 1, 2018 | |
| 76281-522-28 | 76281052228 | 354 mL in 1 BOTTLE (76281-522-28)Marketed from Jan 1, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nighttime Sleep-Aid Non-Habit FormingSuffix: Non-Habit Forming
- Generic name (nonproprietary)
- diphenhydramine hci
- Active ingredients
- Diphenhydramine hydrochloride — 50 mg/30mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- AptaPharma Inc.
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 76281-522_f1654da1-64f7-4c2b-9201-3a7af430ba37SPL ID f1654da1-64f7-4c2b-9201-3a7af430ba37SPL set ID ed0ba7aa-e794-43da-b576-6b9945bf7477RxCUI 1248354UNII TC2D6JAD40UPC 0376281522242, 0376281522259
- Pharmacologic class
- Histamine-1 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476281052224followed by a unit qualifier and the quantityPackage 76281-0522-24. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses ■ reduces time to fall asleep if you have difficulty falling asleep ■ for relief of occasional sleeplessness
Excerpt only. Read the full label for complete information.
Other NDCs under M 017
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| ZENSEZONE Arthmed Temporary Pain Relief Creamcapsaicin, menthol, methyl salicylate | Capsaicin .25 mg/mL + 2 more ingredients | CreamTopical | ZENSEZONE LLC | 82319-240 |
| Quality Choice Lidocaine Pain Relief Patchlidocaine | Lidocaine 4 g/100g | PatchTopical | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | 83324-257 |
| Opravamethyl salicylate, menthol, capsaicin | Methyl salicylate 10 g/100mL + 2 more ingredients | CreamTopical | Biological M.D. Solutions LLC | 83538-102 |
| LidoGuardlidocaine hcl | Lidocaine hydrochloride 4 g/100g | CreamTopical | ViolaCare, Inc. | 85231-200 |
| Kalaya Extra Strength Pain Relief Gel with Arnicamethyl salicylate, menthol, camphor | Methyl salicylate 11 g/100g + 2 more ingredients | GelTopical | Avaria Health & Beauty Corp | 43493-0012 |
| POINT RELIEF COLD SPOT Pain Relievingmenthol | Menthol 120 mg/mL | GelTopical | FABRICATION ENTERPRISES | 51452-450 |
| NeuroMed 7 Topical Pain Relieflidocaine hydrochloride | Lidocaine hydrochloride 4 g/100g | CreamTopical | Sambria Pharmaceuticals, LLC | 54723-175 |
| Solstice Pain Relievingcamphor, menthol, methyl salicylate | Camphor (Synthetic) 3.1 g/100g + 2 more ingredients | PatchTopical | MADISON ONE ACME INC | 55614-210 |
| Peviderm Pramoxine Hydrocholride 1%pramoxine hydrochloride | Pramoxine hydrochloride 1 mg/mL | LotionTopical | Stratus Pharmaceuticals Inc | 58980-913 |
| Stopain Clinicalmenthol | Menthol 100 mg/g | GelTopical | Troy Manufacturing, Inc. | 63936-9751 |
| Alocane Maxlidocaine hydrochloride and benzalkonium chloride | Lidocaine hydrochloride 4 g/100mL; Benzalkonium chloride .13 g/100mL | GelTopical | Quest Products LLC | 68229-406 |
| Lidocare 034% lidocaine | Lidocaine 4 g/1 | PatchTopical | Kingsway Pharmaceuticals dba NFI, LLC | 69993-400 |
| TheraCare Roll-on Lidocaine Pain Relief Liquid - Lavenderlidocaine hci | Lidocaine 4 g/mL | LiquidTopical | Veridian Healthcare | 71101-088 |
| Re-Lieved Lidocaine Patchlidocaine patch 4% | Lidocaine 18 mg/116cm2 | PatchTopical | Transfer Technology | 71662-000 |
| Nuvalu Ice Therapy Menthol Pain Relievingmenthol | Menthol 3 g/100g | GelTopical | JC SALES | 72520-207 |
| SANA SANA Menthol External Analgesicmenthol | Menthol 150 mg/g | GelTopical | Alquimia Najulam S de RL de CV | 72367-000 |
| Rugby Menthol Hot Cold Patchmenthol | Menthol, Unspecified form 5 g/100g | PatchTopical | RUGBY LABORATORIES | 0536-1332 |
| Careland Lidocaine Plus Menthol Pain Relieving Gel Patcheslidocaine, menthol | Lidocaine 40 mg/g; Menthol 10 mg/g | PatchTopical | Planet (Anhui) Pharmaceutical Co., Ltd. | 75568-051 |
| Lidocaine HCl | Lidocaine hydrochloride anhydrous 5 mg/g | GelTopical | Topco Associates LLC | 76162-034 |
| Itch Relief Gel | Diphenhydramine hydrochloride 2 mg/100mL | GelTopical | Pharma Nobis, LLC | 82645-901 |
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