Extra Strength NiteTime Pain Relief
- Product NDC
- 0363-0714
- 11-digit product format
- 003630714
- Labeler code
- 0363
- Product ID
- 0363-0714_3ac05a52-7cce-2bfb-e063-6394a90a134b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen 500 mg,Diphenhydramine Hydrochloride 25 mg Tablet
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- WALGREENS
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-10-12
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 25; 500 mg/1; mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0363-0714-42 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0363-0714-42 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0363-0714-42 | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Extra Strength NiteTime Pain Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1092189 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c25c75c7-157f-1c0d-e053-2995a90a2e3c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-0714-42 | 2025-02-07 | C162847 | 48780-1 | 2cef2736-9e80-d83d-e063-dadaa90ab31f | 430R Walgreens Acetaminophen Diphenhydramine 500 mg/25 mg Caplets-24 counts |
| 0363-0714-42 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9e80-d83d-e063-dadaa90ab31f | 430R Walgreens Acetaminophen Diphenhydramine 500 mg/25 mg Caplets-24 counts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0714-42 | Extra Strength NiteTime Pain Relief | 24 in 1 BOTTLE | TABLET | 24 | 5 | |
| 0363-0714-42 | Extra Strength NiteTime Pain Relief | 1 in 1 CARTON | TABLET | 1 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-0714 | EXTRA STRENGTH NITETIME PAIN RELIEF (ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLET) TABLET [WALGREENS] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250210_c25c75c7-157f-1c0d-e053-2995a90a2e3c.zip |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| foster and thrive infants pain and fever | ACETAMINOPHEN | Strategic Sourcing Services LLC | 45770ad6-9bf7-41bd-a724-e5260cd31fa1 | 2024-10-31 | Warnings | M013 |
| Midol Complete | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLET | Lil' Drug Store Products, Inc. | d20425a4-f074-4154-e053-2995a90ae9fd | 2024-10-30 | Warnings | M013 |
| up and up infants acetaminophen | ACETAMINOPHEN | Target Corporation | 31104956-04d7-41b5-82be-219ded5c02a9 | 2024-10-30 | Warnings | M013 |
| Sunmark Aspirin | ASPIRIN | Strategic Sourcing Services LLC | a7139686-b351-47dc-a395-832429aaa569 | 2024-10-30 | Warnings | M013 |
| Good Neighbor Pharmacy Pain Relief | ACETAMINOPHEN | Amerisource Bergen | 5101125d-4819-4e4b-a0ee-a0ff8d5a0ab1 | 2024-10-30 | Warnings | M013 |
| Acetaminophen | PAIN RELIEVER | McKesson | 9d620700-5d00-475f-e053-2995a90a9a3f | 2024-10-28 | Warnings | M013 |
| Junior Acetaminophen Ages 6-11 | ACETAMINOPHEN | Chain Drug Consortium | d356bc9c-66f1-45c3-a455-98c0b8890f78 | 2024-10-28 | Warnings | M013 |
| leader Acetaminophen | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 36bdcac9-eed4-40f9-a6f2-4c1e773a6b50 | 2024-10-25 | Warnings | M013 |
| GOODYS PM | ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE | Medtech Products Inc. | db5d6c2b-688e-4e88-a42d-0fa2b0d8140b | 2024-10-25 | Warnings | M013 |
| Goodys Extra Strength | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Medtech Products Inc. | 16d774cc-4247-4bf8-9b5a-c338ffebda3d | 2024-10-25 | Warnings | M013 |
| aspirin | ASPIRIN | PUBLIX SUPER MARKETS INC | 9e77ab7a-07e8-42aa-e053-2995a90a0d0e | 2024-10-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Kroger Company | 5bfd9841-c781-43be-b823-d334893ae6ed | 2024-10-24 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | H E B | add6952e-9dd5-487c-93e6-337e9d6a4872 | 2024-10-24 | Warnings | M013 |
| Dye Free Pain Reliever Childrens | ACETAMINOPHEN | Safeway, Inc. | 7d55cb42-295f-473a-941d-71825b44a3c0 | 2024-10-24 | Warnings | M013 |
| rapid release pain relief | ACETAMINOPHEN | Publix Super Markets Inc | d0b34133-d69d-47db-bf51-be942769c612 | 2024-10-24 | Warnings | M013 |
| basic care acetaminophen | ACETAMINOPHEN | Amazon.com Services LLC | 00146b91-008d-4b16-95b0-6077f98821be | 2024-10-24 | Warnings | M013 |
| equate pain reliever | ACETAMINOPHEN | WALMART INC. | 9a20273e-a4d1-4c38-9efb-e6347f8dc14e | 2024-10-24 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | MARC GLASSMAN, INC. | e221905b-a795-c067-e053-2a95a90a02e7 | 2024-10-23 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | MARC GLASSMAN, INC. | e221bbce-83de-0f03-e053-2995a90abca5 | 2024-10-23 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | MARC GLASSMAN, INC. | e231c2f6-927c-1ab0-e053-2995a90a6121 | 2024-10-23 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1092189 | acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | c25c75c7-157f-1c0d-e053-2995a90a2e3c | 5 |
| 1092189 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | c25c75c7-157f-1c0d-e053-2995a90a2e3c | 5 |
| 1092189 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SY | c25c75c7-157f-1c0d-e053-2995a90a2e3c | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0714-42 | 00363071442 | 1 BOTTLE in 1 CARTON (0363-0714-42) / 24 TABLET in 1 BOTTLE | 1 bottle | 2021-10-12 | 0000-00-00 | No | No | Current |