FDA.reportPublic FDA data

topcare all night pain relief pm

Manufacturer
Topco Associates LLC
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:22:19

Label at a glance#

Producttopcare all night pain relief pm
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM
Label structure9 sections

Indications and uses

• for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep

Dosage and administration

• do not take more than directed • drink a full glass of water with each dose • adults and children 12 years and over: take 2 caplets at bedtime • do not take more than 2 caplets in 24 hours • if taken with food, this product may take longer to work

Storage and handling

• read all warnings and directions before use. Keep outer carton. • each caplet contains: sodium 21 mg • store at 20-25°C (68-77°F) • avoid high humidity and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 25 mg

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Nighttime sleep-aid

Pain reliever

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep

Warnings

WARNINGS SECTION

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

OTC - DO NOT USE SECTION

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • unless you have time for a full night’s sleep
  • in children under 12 years of age
  • right before or after heart surgery
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you have glaucoma
  • you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers, or any other sleep-aid
  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other antihistamines
  • taking any other drug

When using this product

OTC - WHEN USING SECTION

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • pain gets worse or lasts more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 caplets at bedtime
  • do not take more than 2 caplets in 24 hours
  • if taken with food, this product may take longer to work

Other information

STORAGE AND HANDLING SECTION

  • read all warnings and directions before use. Keep outer carton.
  • each caplet contains: sodium 21 mg
  • store at 20-25°C (68-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare® health

COMPARE TO ALEVE® pm ACTIVE INGREDIENTS

All Night Pain Relief PM

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE TABLETS, 220 mg / 25 mg

PAIN RELIEVER (NSAID) • NIGHTTIME SLEEP-AID

Sleep Aid Plus 12-Hour Pain Reliever

actual size

20 CAPLETS†

†CAPSULE-SHAPED TABLETS

264-88-all-night-pain-relief-pm.jpg
264-88-all-night-pain-relief-pm.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1550957diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral TabletPSN6
1550957diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral TabletSCD6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codetopbrnds.com/49050g264-88-all-night-pain-relief-pm.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-264-27topcare all night pain relief pm1 in 1 CARTONTABLET, FILM COATED16
36800-264-27topcare all night pain relief pm80 in 1 BOTTLETABLET, FILM COATED806
36800-264-60topcare all night pain relief pm20 in 1 BOTTLETABLET, FILM COATED206
36800-264-60topcare all night pain relief pm1 in 1 CARTONTABLET, FILM COATED16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-26436800-264-60, 36800-264-27

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
NAPROXEN SODIUM9TN87S3A3CACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
FD&C BLUE NO. 2 ALUMINUM LAKE4AQJ3LG584IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM25MG;220MGTABLET / ORAL2019-05-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-1084e616aacf4f…
2026-08-18 06:07:402026-07A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-103f01610625f2…
2019-09-15 20:21 UTC2019-09A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topcare all night pain relief pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMTopco Associates LLCa20f193e-4e64-400a-b605-df08026cb80b2025-12-11WarningsExact identifier
ndc (package): 36800-264-27
ndc (package): 36800-264-60
ndc (product): 36800-264
ndc11 (package): 36800026427
ndc11 (package): 36800026460
spl id: 32352610-bdfc-40f5-8d85-daa6fc9f7ae4
spl set id: a20f193e-4e64-400a-b605-df08026cb80b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.