Nighttime Sleep Aid
- Product NDC
- 69732-005
- 11-digit product format
- 697320005
- Labeler code
- 69732
- Product ID
- 69732-005_55f8f71f-4c2c-6161-e063-6394a90a6a8e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, diphenhydramine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hi-Tech Nutraceuticals, LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-04-30
- 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
- 2027-12-31
- 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 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69732-005-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69732-005-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69732-005-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69732-005-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69732-005-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69732-005-01 | cdf11ea48f46… | ba0047e9e063… |
| 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 | 69732-005-01 | 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 | 69732-005-01 | 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 | 69732-005-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 69732-005-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 69732-005-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 69732-005-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 69732-005-01 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 69732-005-01 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 69732-005-01 | 1332a3947898… | d4bfe170f9cd… |
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
- Nighttime Sleep Aid
- Listing expiration
- 2027-12-31
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 |
|---|---|
| a39e2bd6-3d0a-642b-e053-2995a90a42a0 | 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 |
|---|---|---|---|---|---|
| 69732-005-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1698-111a-e063-dadaa90a10e2 | Sleep Aid |
| 69732-005-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1698-111a-e063-dadaa90a10e2 | Sleep Aid |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69732-005-01 | Nighttime Sleep Aid | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| 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 |
| Pain Relief Extra Strength | ACETAMINOPHEN | MARC GLASSMAN, INC. | e23703bb-6087-7985-e053-2995a90aa5ec | 2024-10-23 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | MARC GLASSMAN, INC. | e237550d-711d-5d87-e053-2995a90affce | 2024-10-23 | Warnings | M013 |
| Aspirin | ASPIRIN | HARRIS TEETER | a6f15f71-1327-4b71-b9d6-e3e9f0243801 | 2024-10-22 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | HARRIS TEETER | 43308b23-7d4f-4e4f-a497-af71920d86aa | 2024-10-22 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1092189 | acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | a39e2bd6-3d0a-642b-e053-2995a90a42a0 | 3 |
| 1092189 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | a39e2bd6-3d0a-642b-e053-2995a90a42a0 | 3 |
| 1092189 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SY | a39e2bd6-3d0a-642b-e053-2995a90a42a0 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69732-005-01 | 69732000501 | 30 TABLET in 1 BOTTLE, PLASTIC (69732-005-01) | 30 tablet | 2020-04-30 | 0000-00-00 | No | No | Current |