Over-the-counter drug · OTC MONOGRAPH DRUG

Rest Simply (Diphenhydramine hydrochloride) NDC 53943-191

Diphenhydramine hydrochloride 25 mg/1 · Tablet, Coated · Oral · DISCOUNT DRUG MART

NDC codes

FDA NDC Directory
Product NDC (as listed)53943-191Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53943-0191Add 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
53943-191-0153943019101539430191014 BLISTER PACK in 1 PACKAGE (53943-191-01) / 6 TABLET, COATED in 1 BLISTER PACKMarketed from Jan 27, 2010
53943-191-0353943019103539430191031 BOTTLE, PLASTIC in 1 CARTON (53943-191-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Jul 10, 2019

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)
Rest Simply
Generic name (nonproprietary)
diphenhydramine hydrochloride
Active ingredients
Diphenhydramine hydrochloride — 25 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
DISCOUNT DRUG MARTNDC labeler code 53943
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 53943-191_38ceed6e-680c-d155-e063-6294a90ab323SPL ID 38ceed6e-680c-d155-e063-6294a90ab323SPL set ID 896ae7b8-cb8d-1aaa-e053-2a95a90a4e1aRxCUI 1049630UNII TC2D6JAD40
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

N453943019101 followed by a unit qualifier and the quantity

Package 53943-0191-01. 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.

Full label on DailyMed (opens in a new tab)

About NDC 53943-191

What is NDC 53943-191?
53943-191 is the product NDC for Rest Simply (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 tablet, coated, listed with the FDA by DISCOUNT DRUG MART. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Rest Simply (Diphenhydramine hydrochloride).
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
DISCOUNT DRUG MART, NDC labeler code 53943. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rest Simply?
5 other product NDCs are listed under this name. See all Rest Simply 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 Rest Simply NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Rest Simplydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHYVEE INC42507-29142507-0291-03
Rest Simplydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-11383324-0113-0183324-0113-24
Rest Simplydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralChain Drug Marketing Association63868-77263868-0772-1063868-0772-24
Rest Simplydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHarris Teeter72036-09172036-0091-01
Rest Simplydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralMarc Glassman, Inc.68998-09168998-0091-01

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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