Over-the-counter drug · OTC MONOGRAPH DRUG
Sleep (Diphenhydramine hcl) NDC 57243-189
Diphenhydramine hydrochloride 25 mg/1 · Tablet · Oral · Salado Sales, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)57243-189Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57243-0189Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57243-189-21 | 5724301892157243018921 | 2 BLISTER PACK in 1 CARTON (57243-189-21) / 8 TABLET in 1 BLISTER PACKMarketed from Apr 10, 1990 |
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)
- Sleep
- Generic name (nonproprietary)
- diphenhydramine hcl
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Salado Sales, Inc.NDC labeler code 57243
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 010
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 57243-189_ac0a5935-31a8-4bba-af05-3f7b8bf8eef9SPL ID ac0a5935-31a8-4bba-af05-3f7b8bf8eef9SPL set ID 837c02dd-971b-4451-98d8-9c438c9db696RxCUI 1049630UNII TC2D6JAD40UPC 0761706166055
- 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
N457243018921followed by a unit qualifier and the quantityPackage 57243-0189-21. 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 for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
Excerpt only. Read the full label for complete information.
About NDC 57243-189
- What is NDC 57243-189?
- 57243-189 is the product NDC for Sleep (diphenhydramine hcl), Diphenhydramine hydrochloride 25 mg/1 tablet, listed with the FDA by Salado Sales, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sleep (Diphenhydramine HCl).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Salado Sales, Inc., NDC labeler code 57243. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sleep?
- 2 other product NDCs are listed under this name. See all Sleep NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sleep products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| sleepaesculus hippocastanum, flos, ferrum phos, kali carb, kali phos, mag phos, nat mur, populus termula, flos, prunus cerasifera, flos | Aesculus hippocastanum flower 5 [hp_X]/29.6mL + 7 more ingredients | SprayOral | Siddha Flower Essences LLC | 69779-012 | 69779-0012-0169779-0012-02 |
| Sleephyoscyamus niger, strychnos ignatii seed, and potassium phosphate, dibasic | Hyoscyamus niger 6 [hp_X]/1 + 2 more ingredients | TabletOral | Hyland's Inc. | 54973-3206 | 54973-3206-01 |
Other NDCs under M 010
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 |
|---|---|---|---|---|
| ADWE dye-free childrens allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SyrupOral | RARITAN PHARMACEUTICALS INC | 68163-710 |
| Allergy Relief 25 mgdiphenhydramine hcl 25mg | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Ulai Health LLC | 73057-348 |
| AXIV - VroZzzdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Vivunt Pharma LLC | 82706-014 |
| basic care nighttime sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | Amazon.com Services LLC | 72288-186 |
| berkley and jensen sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | BJWC | 68391-186 |
| Best Choice Childrens Allergy Relief Bubblegum flavordiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 63941-710 |
| Betr sleep aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Live Betr LLC | 80267-431 |
| Calmco Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/5mL | SolutionOral | CalmCo LLC | 73282-2525 |
| CalmCo Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Chewable gelOral | CalmCo LLC | 73282-2527 |
| CalmCo Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Chewable gelOral | CalmCo LLC | 73282-2528 |
| CalmCo Sleep Aid Gummy Bitediphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Bar, ChewableOral | CalmCo LLC | 73282-2518 |
| careone nighttime sleep aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-431 |
| CVS Childrens Nighttime Multi Symptom Coldacetaminophen , diphenhydramine hydrochloride,phenylephrine hydrochloride | Acetaminophen 325 mg/10mL + 2 more ingredients | LiquidOral | CVS PHARMACY | 51316-733 |
| CVS Health Nighttime Sleep-Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS Pharmacy,Inc. | 59779-893 |
| CVS Nighttime Childrens Cold and Cough Multi-Symptom Reliefchlorpheniramine maleate and dextromethorphan hydrobromide | Chlorpheniramine maleate 2 mg/15mL; Dextromethorphan hydrobromide 15 mg/15mL | SolutionOral | CVS PHARMACY | 51316-752 |
| CVS NightTime Coldacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride | Acetaminophen 650 mg/30mL + 3 more ingredients | SolutionOral | CVS PHARMACY | 51316-641 |
| CVS Nighttime Cold and Flu Reliefacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | CVS PHARMACY | 51316-692 |
| CVS Nighttime Sleep Aiddiphenhydramine hydrochloride and acetaminophen | Acetaminophen 1000 mg/30mL; Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS PHARMACY | 69842-448 |
| dg health sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | Dolgencorp, LLC | 55910-186 |
| dg health sleep aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-431 |
Showing 20 of 40.