good sense nighttime sleep aid
- Product NDC
- 0113-0431
- 11-digit product format
- 001130431
- Labeler code
- 0113
- Product ID
- 0113-0431_70250c98-1eb2-4522-bdc6-7ce5a1468fda
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- L. Perrigo Company
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2001-04-25
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0113-0431 | 0113-0431-68 | D | Discontinued by firm | 2026-10-16 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- good sense nighttime sleep aid
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049630 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ba2adc30-0301-4d53-bce6-fc8b7e34b076 | 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 |
|---|---|---|---|---|---|
| 0113-0431-62 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0a5b-111a-e063-dadaa90a10e2 | Perrigo Nighttime Sleep Aid Drug Facts |
| 0113-0431-68 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0a5b-111a-e063-dadaa90a10e2 | Perrigo Nighttime Sleep Aid Drug Facts |
| 0113-0431-78 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0a5b-111a-e063-dadaa90a10e2 | Perrigo Nighttime Sleep Aid Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0113-0431-62 | good sense nighttime sleep aid | 12 in 1 CARTON | TABLET, FILM COATED | 12 | 5 | |
| 0113-0431-62 | good sense nighttime sleep aid | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 5 | |
| 0113-0431-68 | good sense nighttime sleep aid | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 5 | |
| 0113-0431-68 | good sense nighttime sleep aid | 18 in 1 CARTON | TABLET, FILM COATED | 18 | 5 | |
| 0113-0431-78 | good sense nighttime sleep aid | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 5 | |
| 0113-0431-78 | good sense nighttime sleep aid | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0113-0431-62 | EA - Each | 0113-0431 | 9649502f-c6fa-4d7d-a6f7-a5202e5cda0e | 1 | 2012-07-24 |
| 0113-0431-78 | EA - Each | 0113-0431 | f5f22766-f73c-453c-bdb9-0283651b8829 | 1 | 2024-02-14 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Nighttime sleep aid Maximum Strength | DIPHENHYDRAMINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | 40e73317-5126-4961-8f28-60899ffbec5a | 2024-02-20 | Warnings | M010 |
| Nighttime sleep aid Maximum Strength | DIPHENHYDRAMINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | 2424fb95-06e2-49e7-aea0-7797a37aef4d | 2024-02-20 | Warnings | M010 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy, Inc | f5b609e1-e63b-2e3b-e053-2995a90a76b9 | 2024-02-12 | Warnings | M010 |
| Kroger Nighttime Sleep Aid CAPLET | DIPHENHYDRAMINE HYDROCHLORIDE | The Kroger Co. | f0f3f58d-9457-4697-98e6-ef52d350cf67 | 2024-01-29 | Warnings | M010 |
| Nighttime Sleep Aid | NIGHTTIME SLEEP AID | Allegiant Health | 88feea1d-c961-45e9-b9a6-1418b970aaba | 2024-01-16 | Warnings | M010 |
| Sleep-Aid Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 110, LLC. DBA Leader | 4283558d-62df-4297-bc85-a4e06681a920 | 2024-01-11 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | DeMoulas Market Basket | d3f35102-94ed-4da0-9c29-312e5468fa05 | 2023-12-29 | Warnings | M010 |
| nighttime sleep-aid | DIPHENHYDRAMINE HCL | Bionpharma Inc. | c0074c77-287e-6c26-e053-2995a90a4d31 | 2023-12-26 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYRAMINE HYDROCHLORIDE | TARGET CORPORATION | fac83dad-f6fd-3316-e053-6394a90a99aa | 2023-12-21 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENYDRAMINE HYDROCHLORIDE | TARGET CORPORATION | fc7ed67f-bac9-f9ed-e053-6294a90ad9a1 | 2023-12-16 | Warnings | M010 |
| Sleep-Aid, Circle K | DIPHENHYDRAMINE HCL CAPLET, 25MG | Lil' Drug Store Products, Inc. | d3ad24c4-44ba-6451-e053-2a95a90a1339 | 2023-12-14 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | VALU MERCHANDISERS COMPANY | fed2f7ae-2829-f967-e053-6294a90adc0a | 2023-10-12 | Warnings | M010 |
| Sleep Aid | SLEEP AID | Better Living Brands LLC | 2b730fa5-47f9-468d-86ed-0d49d9cd8dc4 | 2023-07-06 | Warnings | M010 |
| Diphenhydramine HCl 25mg | SLEEP AID | Allegiant Health | 2890e4ba-d642-437d-8a86-24996a74e027 | 2021-11-23 | Warnings | M010 |
| Sleep Aid | SLEEP AID | Allegiant Health | 9a0b347e-5719-42f3-9050-df5165495e88 | 2021-10-14 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Allegiant Health | ec57db48-0f3a-4b12-8633-b45a4366c269 | 2020-11-06 | Warnings | M010 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | ba2adc30-0301-4d53-bce6-fc8b7e34b076 | 5 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | ba2adc30-0301-4d53-bce6-fc8b7e34b076 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0113-0431-62 | 00113043162 | 12 BLISTER PACK in 1 CARTON (0113-0431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK | 12 blister pack | 2001-04-25 | 0000-00-00 | No | No | Current |
| 0113-0431-68 | 00113043168 | 18 BLISTER PACK in 1 CARTON (0113-0431-68) > 2 TABLET, FILM COATED in 1 BLISTER PACK | 18 blister pack | 2019-05-21 | 0000-00-00 | No | No | Current |
| 0113-0431-78 | 00113043178 | 1 BOTTLE in 1 CARTON (0113-0431-78) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-12-29 | 0000-00-00 | No | No | Current |