Over-the-counter drug · OTC MONOGRAPH DRUG
Nighttime Sleep Aid maximum strength (Diphenhydramine hcl) NDC 70000-0527
Diphenhydramine hydrochloride 50 mg/1 · Capsule, Liquid filled · Oral · Cardinal Health (Leader) 70000
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70000-0527Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0527Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0527-1 | 70000052701 | 1 BOTTLE, PLASTIC in 1 BOX (70000-0527-1) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTICMarketed from Oct 20, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 maximum strengthSuffix: maximum strength
- Generic name (nonproprietary)
- diphenhydramine hcl
- Active ingredients
- Diphenhydramine hydrochloride — 50 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Cardinal Health (Leader) 70000NDC labeler code 70000
- 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 70000-0527_85656d4e-1308-4a7b-b0be-f9c19a5f4a37SPL ID 85656d4e-1308-4a7b-b0be-f9c19a5f4a37SPL set ID 546e4fda-6eb2-4358-840e-e2473bf7f352RxCUI 1020477UNII TC2D6JAD40UPC 0096295138801
- 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
N470000052701followed by a unit qualifier and the quantityPackage 70000-0527-01. 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)
Use for relief of occasional sleeplessness.
Excerpt only. Read the full label for complete information.
About NDC 70000-0527
- What is NDC 70000-0527?
- 70000-0527 is the product NDC for Nighttime Sleep Aid maximum strength, Diphenhydramine hydrochloride 50 mg/1 capsule, liquid filled, listed with the FDA by Cardinal Health (Leader) 70000. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nighttime Sleep Aid maximum strength (Diphenhydramine HCl).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Cardinal Health (Leader) 70000, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nighttime Sleep Aid maximum strength?
- 4 other product NDCs are listed under this name. See all Nighttime Sleep Aid maximum strength NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nighttime Sleep Aid maximum strength products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nighttime Sleep Aid Maximum Strengthdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Harris Teeter, LLC | 69256-916 | 69256-0916-32 |
| Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Best Choice (Valu Merchandisers Company) | 63941-916 | 63941-0916-16 |
| Nighttime Sleep Aid Maximum Strengthdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Care One (Retail Business Services, LLC.) | 72476-916 | 72476-0916-32 |
| Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Best Choice (Valu Merchandisers Company) | 63941-860 | 63941-0860-16 |
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 |
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