Over-the-counter drug · OTC MONOGRAPH DRUG

Sleep Aid NightTime (Diphenhydramine hcl) NDC 49580-0314

Diphenhydramine hydrochloride 50 mg/30mL · Liquid · Oral · P & L Development, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)49580-0314Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49580-0314Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
49580-0314-24958003140249580031402355 mL in 1 BOTTLE, PLASTIC (49580-0314-2)Marketed from Aug 31, 2016
49580-0314-44958003140449580031404118 mL in 1 BOTTLE, PLASTIC (49580-0314-4)Marketed from Aug 31, 2016
49580-0314-64958003140649580031406177 mL in 1 BOTTLE, PLASTIC (49580-0314-6)Marketed from Aug 31, 2016

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)
Sleep Aid NightTimeSuffix: NightTime
Generic name (nonproprietary)
diphenhydramine hcl
Active ingredients
Diphenhydramine hydrochloride — 50 mg/30mL
Dosage form
Liquid
Route
Oral
Labeler
P & L Development, LLCNDC labeler code 49580
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 49580-0314_13e7d3b7-fe21-44d9-91cb-d21f051443d0SPL ID 13e7d3b7-fe21-44d9-91cb-d21f051443d0SPL set ID 4144b1a6-aeae-4560-a997-b07206d80350RxCUI 1248354UNII TC2D6JAD40UPC 0349580314047
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

N449580031402 followed by a unit qualifier and the quantity

Package 49580-0314-02. 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 the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49580-0314

What is NDC 49580-0314?
49580-0314 is the product NDC for Sleep Aid NightTime (diphenhydramine hcl), Diphenhydramine hydrochloride 50 mg/30mL liquid, listed with the FDA by P & L Development, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sleep Aid NightTime (Diphenhydramine HCl).
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
P & L Development, LLC, NDC labeler code 49580. 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 Aid NightTime?
14 other product NDCs are listed under this name. See all Sleep Aid NightTime NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sleep Aid NightTime NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-36751316-0367-12
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLLiquidOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-98155910-0981-0255910-0981-04
Sleep Aid Nighttimediphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralTOPCO ASSOCIATES LLC36800-78436800-0784-96
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralUnited Natural Foods, Inc. dba UNFI41163-86041163-0860-3241163-0860-96
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-91655910-0916-1255910-0916-1655910-0916-32+2 more
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralCVS Pharmacy69842-86069842-0860-3269842-0860-6469842-0860-96
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralCVS Pharmacy69842-91669842-0916-0269842-0916-3269842-0916-64+1 more
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLLiquidOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-89955910-0899-12
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-67249035-0672-51
Sleep-Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralCVS PHARMACY69842-67269842-0672-51

All 15 Sleep Aid NightTime NDCs

Other NDCs under M 010

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 010
ProductStrengthForm · routeLabelerProduct NDC
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophenDiphenhydramine hydrochloride 50 mg/30mL; Acetaminophen 1000 mg/30mLLiquidOralThe Procter & Gamble Manufacturing Company69423-985
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralBJWC (Berkley & Jensen / BJ's)68391-793
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-736
Diphenhydramine HCl 25mgsleep aidDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralAllegiant Health69168-002
berkley and jensen sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralBJWC68391-186
AXIV - VroZzzdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralVivunt Pharma LLC82706-014
Revasol Sleep Aiddiphenhydramine hclDiphenhydramine HCl 50 mg/30mLLiquidOralRnv LLC84379-284
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophenDiphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1Tablet, CoatedOralThe Procter & Gamble Manufacturing Company37000-974
Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBest Choice (Valu Merchandisers Company)63941-860
Sleep Tabsdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1TabletOralMajor Pharmaceuticals0904-4274
Nightime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralBETTER LIVING BRANDS LLC.21130-711
Diphenhydramine HClDiphenhydramine HCl 50 mg/30mLLiquidOralBI-MART37835-519
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-672
Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBest Choice (Valu Merchandisers Company)63941-916
Nighttime Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBIONPHARMA INC.69452-427
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralAAA Pharmaceutical, Inc.57344-091
Sleep AidDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBetter Living Brands LLC21130-052
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-894
Quality Choice Nighttime Sleep-Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralChain Drug Marketing Association, Inc.63868-970
Nighttime Sleep Aiddiphenhydramine hcl 50mgDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralGrocery Outlet85828-410

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