Over-the-counter drug · OTC MONOGRAPH DRUG

Sominex (Diphenhydramine hydrochloride) NDC 67751-221

Diphenhydramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Navajo Manufacturing Company Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)67751-221Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67751-0221Add 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
67751-221-0167751022101677510221011 BLISTER PACK in 1 CARTON (67751-221-01) / 8 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 1, 2012

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)
Sominex
Generic name (nonproprietary)
diphenhydramine hydrochloride
Active ingredients
Diphenhydramine hydrochloride — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Navajo Manufacturing Company Inc.NDC labeler code 67751
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 67751-221_2396151b-13a0-cc41-e063-6394a90aa45bSPL ID 2396151b-13a0-cc41-e063-6394a90aa45bSPL set ID f70ce1a6-c334-025e-e053-6294a90ae53fRxCUI 1049630, 1086986UNII 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

N467751022101 followed by a unit qualifier and the quantity

Package 67751-0221-01. 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 helps reduce difficultly falling asleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67751-221

What is NDC 67751-221?
67751-221 is the product NDC for Sominex (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Navajo Manufacturing Company Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sominex (Diphenhydramine hydrochloride).
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
Navajo Manufacturing Company Inc., NDC labeler code 67751. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sominex?
1 other product NDC are listed under this name. See all Sominex 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 Sominex NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sominexdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralMedtech Products Inc.63029-55463029-0554-0163029-0554-1663029-0554-32

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
Nighttime Sleep Aid maximum strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralCardinal Health (Leader) 7000070000-0527
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralBetter Living Brands, LLC21130-763
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophenDiphenhydramine hydrochloride 50 mg/30mL; Acetaminophen 1000 mg/30mLLiquidOralThe Procter & Gamble Manufacturing Company69423-985
CVS NightTime Coldacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochlorideAcetaminophen 650 mg/30mL + 3 more ingredientsSolutionOralCVS PHARMACY51316-641
Nighttime Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralDISCOUNT DRUG MART, INC.53943-485
nighttime sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralAmazon.com Services LLC72288-765
Nighttime Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralCare One (Retail Business Services, LLC.)72476-916
CalmCo Sleep Aid Gummy Bitediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Bar, ChewableOralCalmCo LLC73282-2518
Diphenhydramine Hydrochloridediphenhydramine hydrochloride capsule, liquid filledDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralAMZ789 LLC73629-007
Nightime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralBETTER LIVING BRANDS LLC.21130-711
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralWalgreen Company0363-8020
Nighttime Sleep Aiddiphenhydramine hcl 50mgDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralGrocery Outlet85828-410
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-672
Good Sense Sleep Timediphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralL. Perrigo Company0113-0186
Diphenhydramine HClDiphenhydramine HCl 50 mg/30mLLiquidOralBI-MART37835-519
Calmco Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/5mLSolutionOralCalmCo LLC73282-2525
berkley and jensen sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralBJWC68391-186
Nighttime Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBIONPHARMA INC.69452-427
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralFamily Dollar (FAMILY WELLNESS)55319-564
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralQUALITY CHOICE (Chain Drug Marketing Association)63868-900

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